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Takeda announces that the FDA has granted a priority assessment to the additional request for a new drug for ALUNBRIG?(brigatinib)

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Takeda announces that the FDA has granted a priority assessment to the additional request for a new drug for ALUNBRIG?(brigatinib)

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Takeda announces that the FDA has granted a priority assessment to the additional request for a new drug for ALUNBRIG?(brigatinib)

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[caption id="attachment_9277" align="aligncenter" width="747"]Press Release Press Release[/caption]

- ALUNBRIG has the potential to broaden its indication for ALK + metastatic non-small cell lung cancer -

- Under the Prescription Drug User Fee Act (PDUFA), the target date is June 23, 2020 -

February 25, 2020 02:44 AM Eastern Standard Time

CAMBRIDGE, Massachusetts, and OSAKA, Japan - (?BUSINESS WIRE?) -? Takeda Announces FDA Has Prioritized the Additional Request for New Drug for ALUNBRIG???(brigatinib)?as First-?Line?Treatment for Cancer Cancer ALK + metastatic non-small cell lung?

T?akeda Pharmaceutical Company Limited?(TSE: 4502 / NYSE: TAK)?announces today that the United States Food and Drug Administration has granted a priority review to the company's Supplemental New Drug Request (sNDA) in preparation for to expand the use of ALUNBRIG (brigatinib) as a first-line treatment for patients with metastatic non-small cell lung cancer like ALK + (anaplastic lymphoma kinase) detected by an FDA approved test .?ALUNBRIG is a new generation tyrosine kinase (ITK) inhibitor designed to target and inhibit genetic alterations in ALK.

??NSCLC ALK + is a rare and serious form of lung cancer that is difficult to treat.?Although progress has been made, unmet needs still exist for approximately 40,000 patients who are diagnosed worldwide each year, "said Christopher Arendt, head of the Oncology Therapy Unit at Takeda.?"?This is an important first step in expanding treatment options for people with metastatic ALK + NSCLC in the United States, and we look forward to continuing to work alongside regulatory authorities around the world to offer ALUNBRIG to newly diagnosed patients.?" The sNDA for ALUNBRIG as a first-line treatment is based on the results of the ALTA-1L Phase 3 trial, which evaluates the safety and efficacy profile of ALUNBRIG in patients with NSCLC. Locally advanced or metastatic ALK + that has not already received treatment with an ALK inhibitor, compared to that of crizotinib in the same population.?The ALTA-1L trial met its primary endpoint, ALUNBRIG demonstrating superiority over crizotinib in terms of progression-free survival (PFS) assessed blindly by an independent review committee. About the ALTA-1L trial The ALTA-1L (?A?LK in?L?ung Cancer?T?rial of Brig?A?tinib in?1?st?L?ine) Phase 3 trial of ALUNBRIG in adults is a current, randomized, open, comparative and multicenter global study of 275 patients (ALUNBRIG, n = 137, crizotinib, n = 138) suffering from locally advanced or metastatic NSCLC already never treated with an ALK inhibitor.?Patients received either 180 mg ALUNBRIG once daily with a seven-day preparatory phase to 90 mg once daily, or 250 mg crizotinib twice daily. The median age was 58 years in the ALUNBRIG group and 60 years in the crizotinib group.?Twenty-nine percent of patients had baseline brain metastases in the ALUNBRIG group, and 30% in the crizotinib group.?Twenty-six percent of patients had previously received chemotherapy for an advanced or metastatic disease in the ALUNBRIG group, compared to 27% in the crizotinib group. Progression-free survival (PFS), assessed blindly by an independent review committee (IEC), was the primary endpoint.?Secondary endpoints included objective response rate (ORR) according to RECIST v1.1, intracranial ORT, intracranial PFS, overall survival (OS), safety and tolerability. The safety profile of ALUNBRIG during the ALTA-1L trial was generally consistent with current prescribing information in the United States. About ALUNBRIG???(brigatinib) ALUNBRIG is a new generation, powerful and selective tyrosine kinase (ITK) inhibitor, designed to target and inhibit genetic alterations in the anaplastic lymphoma kinase (ALK).?In April 2017, ALUNBRIG received accelerated approval from the Food and Drug Administration (?FDA?) for the treatment of patients with metastatic ALK + NSCLC who have had their disease progressed by taking crizotinib or who are intolerant to it.?This indication is approved under expedited authorization based on the tumor response rate and the duration of the response.?Continued authorization for this indication may be subject to verification and description of the clinical benefits as part of a confirmatory trial. ALUNBRIG is currently approved in more than 40 countries, including the United States, Canada and the European Union, for the treatment of patients with ALK + metastatic NSCLC who have worsened during treatment with crizotinib or who cannot tolerate taking crizotinib. ALUNBRIG received revolutionary FDA treatment designation for the treatment of ALK + NSCLC patients whose tumors are resistant to crizotinib, and received the FDA orphan drug designation for the treatment of ALK +, ROS1 + NSCLC EGFR +. About NSC + ALK + Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for about 85% of the 1.8 million new cases of lung cancer diagnosed worldwide each year, according to the World Organization of health.?1,2?Genetic studies indicate that chromosomal rearrangements of anaplastic lymphoma kinase (?ALK?) are key drivers in a subgroup of patients with NSCLC.?3?Between three and five percent of patients with metastatic NSCLC have a rearrangement of the?ALK?gene?.?4,5,6 Takeda is committed to continuing its research and development efforts for the NSCLC to improve the lives of the approximately 40,000 patients diagnosed with this serious and rare form of lung cancer each year worldwide.?7 Takeda's commitment to lung cancer Takeda is committed to diversifying the therapeutic options against NSCLC ALK + and NSCLC with mutation of EGFR / HER2.?Our comprehensive programs include the following clinical trials to continue to meet the unmet needs of people with lung cancer: ALUNBRIG
  • Phase 1/2?trial to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ALUNBRIG.?This essay has completed its recruitment.
  • Pivotal Phase 2 ALTA?trial evaluating the efficacy and safety of ALUNBRIG with two dosages in patients with locally advanced or metastatic ALK + NSCLC who progressed during treatment with crizotinib.?This essay has completed its recruitment.
  • Global randomized?ALTA-1L Phase 3?trial evaluating the efficacy and safety of ALUNBRIG compared to crizotinib in patients with locally advanced or metastatic ALK + NSCLC who have not yet received treatment with an ALK inhibitor.?This essay has completed its recruitment.
  • Single-group, multicenter?J-ALTA Phase 2?trial in Japanese patients with ALK + NSCLC targeting patients with disease progression while taking alectinib.?This essay has completed its recruitment.
  • Phase 2?, global, single-group?ALTA 2?trial evaluating ALUNBRIG in patients with advanced ALK + NSCLC who progressed while taking alectinib or ceritinib.?This essay has completed its recruitment.
  • A?global, randomized?Phase 3 ALTA 3?trial comparing the efficacy and safety of ALUNBRIG versus alectinib in participants with NSCLC ALK + who progressed while taking crizotinib.?This trial is currently in the recruitment phase.
TAK-788, a selective inhibitor of EGFR / HER2 mutations, currently being explored for insertion mutations in exon 20 of EGFR:
  • Phase 1/2 study?evaluating the safety, pharmacokinetics and antitumor activity of TAK-788, an EGFR / HER2 inhibitor, orally in patients with NSCLC.?This essay has completed its recruitment.
  • EXCLAIM Phase 2 pivotal extension cohort from?the Phase 1/2 trial to assess the efficacy and safety of TAK-788 at a single daily dose of 160 mg in previously treated patients with d mutations insertion into exon 20 of the EGFR.?This essay has completed its recruitment.
  • EXCLAIM 2 Phase 3?Global Randomized?Study Evaluating?the Efficacy of TAK-788 as a First-Line Treatment Compared to Double Platinum-Based Chemotherapy in Treatment-Na?ve Patients with Locally Advanced NSCLC or metastatic whose tumors include insertion mutations in exon 20 of EGFR.?This trial is currently in the recruitment phase.
  • Phase 1?, open, multicenter, increasing dose study evaluating the safety, tolerability and pharmacokinetics of TAK-788 in Japanese patients with locally advanced or metastatic NSCLC.?This essay has completed its recruitment.
  • Open and multicenter?J-EXCLAIM Phase 2?study evaluating the efficacy of TAK-788 as a first-line treatment in Japanese patients with locally advanced or metastatic NSCLC whose tumors have insertion mutations in exon 20 of the EGFR.?This trial is currently in the recruitment phase.
  • Phase 1?, open, two-?phase?, fixed-sequence study to characterize the drug-drug interaction between TAK-788 and a potent cytochrome P-450 (CYP) 3A inhibitor, itraconazole (part 1), or a strong inducer of CYP3A, rifampin (part 2), in healthy adult subjects.?This trial is currently in the recruitment phase.
For additional clinical trial information on ALUNBRIG and TAK-788, please visit?www.clinicaltrials.gov?. IMPORTANT INFORMATION RELATING TO THE SAFETY OF ALUNBRIG WARNINGS AND PRECAUTIONS Interstitial lung disease (IPD) / Pulmonary disease:?Serious adverse reactions, life-threatening or fatal, of a pulmonary nature and suggestive of interstitial lung disease (PID) / pneumonia, have occurred with ALUNBRIG.?In the ALTA trial (ALTA), PID / pneumonitis occurred in 3.7% of patients in the 90 mg group (single daily dose of 90 mg) and in 9.1% of patients in the 90 ? 180 group mg (single daily dose of 180 mg after a preparatory period of seven days to 90 mg in single daily dose).?Adverse reactions suggestive of MPI / pneumonitis occurred early (within 9 days of starting ALUNBRIG; median onset of 2 days) in 6.4% of patients, grade 3 reactions or 4 occurring in 2.7% of them.?Watch for the onset or worsening of respiratory symptoms (e.g. dyspnea, cough, etc.), especially during the first week of taking ALUNBRIG.?Do not administer ALUNBRIG to a patient with new or worsening respiratory symptoms, and assess quickly for MPI / pneumonia or other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2.?especially during the first week of taking ALUNBRIG.?Do not administer ALUNBRIG to a patient with new or worsening respiratory symptoms, and assess quickly for MPI / pneumonia or other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2.?especially during the first week of taking ALUNBRIG.?Do not administer ALUNBRIG to a patient with new or worsening respiratory symptoms, and assess quickly for MPI / pneumonia or other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2.?Do not administer ALUNBRIG to a patient with new or worsening respiratory symptoms, and assess quickly for MPI / pneumonia or other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2.?Do not administer ALUNBRIG to a patient with new or worsening respiratory symptoms, and assess quickly for MPI / pneumonia or other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2.?other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2.?other causes of respiratory symptoms (eg, pulmonary embolism, tumor progression or infectious pneumonia).?For grade 1 or 2 MPI / pneumonitis, you can either resume administration of ALUNBRIG by reducing the dose after recovery to baseline, or permanently discontinue administration of the drug.?Permanently stop the administration of ALUNBRIG in case of PID / pneumonia of grade 3 or 4, or of reappearance of PID / pneumonia of grade 1 or 2. Hypertension:In the ALTA trial, hypertension was reported in 11% of patients in the 90 mg group who received ALUNBRIG and in 21% of patients in the 90 ? 180 mg group.?Grade 3 hypertension occurred in 5.9% of all patients.?Check blood pressure before treatment with ALUNBRIG.?Monitor blood pressure after 2 weeks, then at least once a month during treatment with ALUNBRIG.?Stop ALUNBRIG administration in case of grade 3 hypertension despite optimal antihypertensive treatment.?After resolution or return to grade 1 severity, resume administration of ALUNBRIG by reducing the dose.?Consider permanent discontinuation of ALUNBRIG treatment in case of grade 4 hypertension or reoccurrence of grade 3 hypertension. Bradycardia:Bradycardia can occur with ALUNBRIG.?During the ALTA trial, heart rates below 50 beats per minute occurred in 5.7% of patients in the 90 mg group and in 7.6% of patients in the 90 ? 180 mg group.?Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg group.?Monitor heart rate and blood pressure during treatment with ALUNBRIG.?Monitor patients more frequently if the concomitant use of a drug known to cause bradycardia cannot be avoided.?In the event of symptomatic bradycardia, discontinue administration of ALUNBRIG and evaluate concomitant medications which are known to cause bradycardia.?If a concomitant medicinal product known to cause bradycardia is identified and its administration interrupted or adjusted, resume administration of ALUNBRIG at the same dosage after disappearance of symptomatic bradycardia;?otherwise reduce the dose of ALUNBRIG after the symptomatic bradycardia has disappeared.?Stop administration of ALUNBRIG in the event of life-threatening bradycardia if no concomitant contributing drug is identified. Visual disturbances:During the ALTA trial, adverse reactions leading to visual disturbances, including blurred vision, diplopia and reduced visual acuity, were reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group and in 10 % of patients in group 90 ? 180 mg.?Grade 3 macular edema and cataracts occurred in one patient, each in the 90 ? 180 mg group.?Advise patients to report any visual symptoms.?Stop administration of ALUNBRIG and request an ophthalmological assessment for patients with new or worsening visual symptoms, grade 2 or more severe.?After return of grade 2 or 3 visual disturbances to grade 1 or to the reference level, resume administration of ALUNBRIG by reducing the dose. Elevated creatine phosphokinase (CPK):During the ALTA trial, an increase in creatine phosphokinase (CPK) occurred in 27% of patients receiving ALUNBRIG in the 90 mg group and in 48% of patients in the 90 ? 180 mg group.?The incidence of grade 3 or 4 CPK elevation was 2.8% in the 90 mg group and 12% in the 90 ? 180 mg group.?Dose reduction due to CPK elevation was performed in 1.8% of patients in the 90 mg group and in 4.5% of those in the 90 ? 180 mg group.?Advise patients to report any unexplained muscle pain, tenderness or weakness.?Monitor CPK levels during treatment with ALUNBRIG.?Stop the administration of ALUNBRIG in case of elevation of the CPK of grade 3 or 4. After resolution or return to grade 1 or to the reference level, resume the Elevation of pancreatic enzymes:In the ALTA trial, amylase elevation occurred in 27% of patients in the 90 mg group and in 39% of patients in the 90 ? 180 mg group.?Lipase elevation occurred in 21% of patients in the 90 mg group and in 45% of patients in the 90 ? 180 mg group.?Grade 3 or 4 amylase elevation occurred in 3.7% of patients in the 90 mg group and in 2.7% of patients in the 90 ? 180 mg group.?Grade 3 or 4 lipase elevation occurred in 4.6% of patients in the 90 mg group and in 5.5% of patients in the 90 ? 180 mg group.?Monitor lipase and amylase during treatment with ALUNBRIG.?Stop administration of ALUNBRIG in case of elevation of grade 3 or 4 pancreatic enzymes. After resolution or return to grade 1 or to the reference level, Hyperglycemia:During the ALTA trial, 43% of patients who received ALUNBRIG suffered from new or worsening hyperglycemia.?Grade 3 hyperglycemia, based on a laboratory assessment of fasting blood sugar levels, occurred in 3.7% of patients.?Two out of 20 (10%) patients with diabetes or early glucose intolerance needed to start insulin therapy while taking ALUNBRIG.?Assess the fasting blood sugar before starting ALUNBRIG administration and monitor it periodically thereafter.?Start or optimize the administration of anti-hyperglycemic drugs, as needed.?If adequate control of hyperglycemia cannot be achieved with optimal medical management, discontinue administration of ALUNBRIG until Embryo-fetal toxicity:?Based on its mechanism of action and on results obtained in animals, ALUNBRIG may harm the fetus if administered to pregnant women.?There are no clinical data from the use of ALUNBRIG in pregnant women.?Inform pregnant women of the potential risk to the fetus.?Advise women of childbearing potential to use effective non-hormonal contraception during treatment with ALUNBRIG, and for at least 4 months after administration of the last dose.?Advise men with female partners of childbearing potential to use effective contraception during treatment, and for at least 3 months after the last dose of ALUNBRIG. SIDE EFFECTS Serious adverse reactions occurred in 38% of patients in the 90 mg group and in 40% of patients in the 90 ? 180 mg group.?The most common serious adverse reactions were pneumonia (5.5% in total, 3.7% in the 90 mg group and 7.3% in the 90 ? 180 mg group) and PID / pneumonia (4, 6% in total, 1.8% in the 90 mg group and 7.3% in the 90 ? 180 mg group).?Fatal adverse reactions occurred in 3.7% of patients and took the following forms: pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urinary tract infection (1 patient for each condition). The most common adverse reactions (=25%) in the 90 mg group were nausea (33%), fatigue (29%), headache (28%) and dyspnea (27%) and group 90 ? 180 mg, nausea (40%), diarrhea (38%), fatigue (36%), cough (34%) and headache (27%). DRUGS INTERACTIONS CYP3A inhibitors?: Avoid co-administration of ALUNBRIG with strong or moderate inhibitors of CYP3A.?Avoid grapefruit and grapefruit juice as they may also increase the plasma concentrations of brigatinib.?If concomitant administration of a strong or moderate inhibitor of CYP3A cannot be avoided, reduce the dose of ALUNBRIG. CYP3A Inducers?: Avoid co-administration of ALUNBRIG with strong or moderate CYP3A inducers.?If concomitant administration of moderate CYP3A inducers cannot be avoided, increase the dose of ALUNBRIG. CYP3A Substrates?: Co-administration of ALUNBRIG and sensitive substrates of CYP3A, including hormonal contraceptives, may cause a reduction in the concentrations and loss of efficacy of the sensitive substrates of CYP3A. USE IN SPECIFIC POPULATIONS Pregnancy:?ALUNBRIG?may harm the unborn?child?.?Inform women of childbearing age of the potential risk to the fetus. Breastfeeding:?There are no data on the secretion of brigatinib in breast milk or its effects on the breastfed infant or milk production.?Because of the risk of side effects in breast-fed infants, breast-feeding women should be advised not to breast-feed while taking ALUNBRIG. Women and men of childbearing age: Pregnancy test?: Confirm a possible pregnancy in women of childbearing potential before starting treatment with ALUNBRIG. Contraception?:?Advise women of childbearing age to use effective non-hormonal contraception during treatment with ALUNBRIG, and for at least 4 months after the last dose.?Advise men with female partners of childbearing potential to use effective contraception during treatment with ALUNBRIG, and for at least 3 months after administration of the last dose. Sterility?: ALUNBRIG can cause reduced fertility in men. Pediatric use:?The safety and efficacy of ALUNBRIG in pediatric patients have not been established. Geriatric Use:?Clinical studies of ALUNBRIG did not include a sufficient number of patients 65 years of age or older to determine if they respond differently from younger patients. Hepatic or renal impairment:?No dose adjustment is recommended for patients with mild or moderate hepatic impairment or mild or moderate renal impairment.?Reduce the dose of ALUNBRIG for patients with severe hepatic impairment or severe renal impairment. Please see the full U.S. prescribing information for ALUNBRIG at?www.ALUNBRIG.com About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited (?TSE: 4502 / NYSE: TAK) is a global biopharmaceutical leader, focused on R&D and value-oriented, based in Japan, whose mission is to provide better health and a better future for patients, by converting science into highly innovative drugs.?Takeda focuses its R&D efforts on four therapeutic areas: oncology, gastroenterology (GI), rare diseases and neuroscience.?We are also making targeted R&D investments in plasma-derived therapies and vaccines.?We focus on developing highly innovative drugs that help make a difference in people's lives.?To achieve this, we are pushing the boundaries of new treatment options and harnessing our capabilities and our R & D engine.?Collaborative and optimized to create a robust pipeline, with various modalities.?Our employees are committed to improving the quality of life for patients and to working with our healthcare partners in approximately 80 countries and regions. For more information, please visit?https://www.takeda.com Important Notice For the purposes of this communication, ?press release? means this document, any oral presentation, any question and answer session and any written or oral document commented on or distributed by Takeda Pharmaceutical Company Limited (??Takeda?) Regarding this press release.?This press release (including any oral report and question-and-answer session relating thereto) does not aim, constitute, represent or form part of any offer, invitation or solicitation to sell or acquire, subscribe, exchange, sell or transfer a vote or approval title or solicitation in any jurisdiction No action or other security is offered to the public by means of this press release.?No offer of securities must be made in the United States, unless registration has been made under the United States Securities Act of 1933, as amended, or in the event of exemption from it.?This press release is distributed (together with any other information that may be provided to the recipient) on the condition that it will only be used by the recipient for information purposes (and not to evaluate any investment, acquisition, assignment or other transaction).?Failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly or indirectly holds investments are separate entities.?In this press release, "Takeda" is sometimes used for convenience when reference is made to Takeda or its subsidiaries in general.?Similarly, the terms "we", "us" and "our" are also used to refer to subsidiaries in general or the people who work for them.?These expressions are also used when the identification of such company (ies) does not serve any useful purpose. Forward-looking statements This press release and all documents distributed in connection with it may contain forward-looking statements, beliefs or opinions regarding future business, future positioning and the results of Takeda's operations, these may be estimates, forecasts, goals and plans for Takeda.?Forward-looking statements often include, but are not limited to, terms such as "target", "plan", "think", "hope", "continue", "expect", "ambition", " foresees ?,? ensures that ?,? anticipates ?,? estimates ?,? projects ?the use of verbs in the future or conditional, of words or terms of a similar nature or their negative formulation.?The forward-looking statements in this document are based on Takeda's estimates and assumptions and are only valid as of the date hereof. Such forward-looking statements are not a guarantee of Takeda or its management regarding future performance ;?they involve known and unknown risks, uncertainties and other factors including, but not limited to: the economic environment surrounding Takeda's global operations, including the general economic situation in Japan and the United States;?competitive pressures and advances;?changes in applicable laws and regulations;?the success or failure of product development programs;?regulatory authorities' decisions and timing;?fluctuations in interest and exchange rates;?complaints and problems regarding the safety or efficacy of marketed products or product candidates;?the timing and impact of post-merger integration efforts for the acquired companies;?and the ability to sell assets that are not part of Takeda's core operations and the timetable for the sales in question;?as many elements likely to cause a significant difference between the results, the performance, the realizations or the financial situation of Takeda and the results, the performance, the realizations or the financial situation of the company expressed or implied in the said forward-looking statements.?For more information about these and other factors that may affect results, performance,?Takeda's achievements or financial position, please see ?Item 3. Key Information ? D.?Risk Factors ?in Takeda's latest annual report on Form 20-F and other Takeda reports filed with the US Securities and Exchange Commission (the" SEC "), available on Takeda's website athttps://www.takeda.com/investors/reports/sec-filings/?or on?

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