Shots:
- The US FDA approved 8 NDAs and 1 BLA in January 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 9 novel products in 2023
- In January 2023, the major highlights drugs were Rykindo (risperidone) approval for schizophrenia and bipolar 1 disorder, Brenzavvy (bexagliflozin) for type 2 diabetes
- PharmaShots has compiled a list of a total of 9 new drugs approved by the US FDA in January 2023
Eisai and Biogen Receive the US FDA’s Approval of Leqembi (lecanemab-irmb) for Alzheimer’s Disease
Leqembi
Active ingredient: lecanemab-irmb Approved: January 09, 2023
Company: Eisai and Biogen Disease: Alzheimer Disease
- The US FDA has approved Leqembi (100mg/mL, IV, q2w) for AD under the accelerated approval pathway. The product is expected to be available during or before Jan 23, 2023
- The approval was based on the P-II study of Leqembi (humanized IgG1 mAb) which showed a reduction in the accumulation of Aβ plaque in the brain. The company also submitted sBLA to the US FDA for approval under the traditional pathway, based on the P-III trial (Clarity AD) presented at CTAD conference & published in the NEJM
- The company launched the patient support program, providing access to patients for Leqembi treatment incl. insurance coverage & co-pay programs. At the same time, PAP offers Leqembi at no cost for eligible uninsured & underinsured patients, incl. Medicare beneficiaries
Airsupra
Active ingredient: albuterol and budesonide Approved: January 12, 2023
Company: AstraZeneca and Avillion Disease: Asthma
- The US FDA has approved Airsupra (albuterol/budesonide) for as-needed treatment or prevention of bronchoconstriction & to reduce the risk of exacerbations in patients with asthma aged ≥18yrs.
- The approval was based on the P-III trial (MANDALA) & (DENALI) evaluating PT027 vs albuterol in 3132 & 1001 adults and children aged 4-11yrs. Both trials met their 1EPs i.e., reductions in risk of sev. exacerbations over albuterol, when used as a rescue medicine in response to symptoms in (MANDALA) trial, added ICS alone or in combination with asthma maintenance therapies
- In the (DENALI) trial, lung function improved as measured by FEV1 over albuterol & budesonide. The safety & tolerability in both trials were consistent with the known profiles
Rykindo
Active ingredient: risperidone Approved: January 16, 2023
Company: Luye Pharma Disease: Schizophrenia and Bipolar 1 Disorder
- Rykindo has received approval from the US FDA for extended-release injectable suspension for the treatment of schizophrenia & as monotx. or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults
- Rykindo is a long-acting risperidone inj. & marks the first innovative therapy to be marketed in the US. The therapy was administered via IV, q2w uses long-acting, extended-release microsphere technology to deliver the active component, risperidone which was approved for marketing in China for schizophrenia
- Rykindo’s development is moving forward in the EU & the company is planning to launch the therapy in more countries and regions globally
BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia
Brukinsa
Active ingredient: zanubrutinib Approved: January 20, 2023
Company: BeiGene Disease: Chronic Lymphocytic Leukemia
- The approval was based on the results from the P-III studies (ALPINE) in 652 patients & (SEQUOIA) trial in 740 patients evaluating Brukinsa. The results showed superior efficacy & favorable safety profile
- In the (SEQUOIA) trial, the results showed a PFS benefit over bendamustine + rituximab with a median follow-up of 26.2mos. In the (ALPINE) trial, superior ORR over ibrutinib, ORR (80.4% vs 72.9%) while the overall safety profile in both trials was consistent with prior studies
- In the pre-defined final PFS analysis of the (ALPINE) study, superior PFS with a median follow-up of 29.6mos., favorable cardiac safety profile with lower rates of AF/flutter (5.2% vs 13.3%) & zero deaths due to cardiac disorders (0% vs 1.9%)
Brenzavvy
Active ingredient: bexagliflozin Approved: January 24, 2023
Company: TheracosBio Disease: Type 2 Diabetes
- The US FDA has approved Brenzavvy, an oral sodium-glucose cotransporter 2 inhibitor that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D
- The approval was based on the results from a clinical program in 23 clinical trials evaluating the safety & efficacy of Brenzavvy in 5000+ adult patients with T2D mellitus. The P-III studies showed a reduction in hemoglobin A1c & fasting blood sugar after 24wks. as monotx & in combination with metformin, or as an add-on to SoC treatment
- Brenzavvy will be available as 20mg oral tablets to be taken qd. The one P-II trial results showed that the therapy was well-tolerated & provide a durable & clinical improvement in glycemic control over 96wks.
Bravecto
Active ingredient: fluralaner Approved: January 27, 2023
Company: Merck Animal Health Disease: Asian Long-Horned Ticks in Dogs
- The company has expanded the indication for Bravecto Chews to include the treatment & control of Asian long-horned ticks in dogs
- Through the US FDA approval, Merck has been able to extend its Bravecto product portfolio to provide a broad-spectrum comprehensive line of parasite protection products delivering immediate & persistent killing activity in dogs
- Bravecto (112.5, 250, 500, 1000 & 1400 mg fluralaner/chew) is a chewable tablet indicated for the treatment & prevention of flea infestations, treatment & control of Amblyomma americanum infestations (for 8wks.), tick infestations, Dermacentor variabilis, Rhipicephalus sanguineus & Haemaphysalis longicornis (for 12wks.)
Keytruda
Active ingredient: pembrolizumab Approved: January 30, 2023
Company: Merck Disease: Non-Small Cell Lung Cancer
- The approval was based on the P-III trial (KEYNOTE-091) results evaluating Keytruda (200mg, IV, q3w) vs PBO in a ratio (1:1) in 1177 patients with completely resected stage IB (T2a ≥4 cm), II, or IIIA NSCLC
- The results showed an improvement in DFS who received adjuvant Pt-based CT following surgical resection, a 27% reduction in risk of disease recurrence or death, m-DFS (58.7mos. vs 34.9mos.) in patients regardless of PD-L1 expression
- In an exploratory subgroup analysis, the DFS HR was 1.25 among 167 patients who did not receive adjuvant CT while the AEs reported in the trial (KEYNOTE-091) were similar to that observed in other trials of pembrolizumab
Jaypirca
Active ingredient: pirtobrutinib Approved: January 30, 2023
Company: Eli Lilly Disease: Mantle Cell Lymphoma
- The US FDA has approved Jaypirca (100/50mg) for adult patients with r/r MCL after two lines of systemic therapy. The approval was based on the P-I/II trial (BRUIN) includes a P-I dose-escalation phase, a P-Ib combination arm, and a P-II dose-expansion phase evaluating Jaypirca in 120 patients
- The results showed that patients treated with Jaypirca (200mg) achieved an ORR (50%), CR (13%), PR (38%), and median time to response (1.8mos.) and m-DoR was 8.3mos., 6mos. DoR rate (65.3%) while 83% discontinued the last BTK inhibitor due to refractory or progressive disease. In the pooled safety analysis, adverse reactions were reported in ≥20%
- Dose reductions & treatment interruptions due to AEs in 4.7% & 32%, respectively, and permanent discontinuation of the study drug (9%)
Orserdu
Active ingredient: elacestrant Approved: January 31, 2023
Company: Context Therapeutics Disease: Mutated Breast Cancer
- The US FDA has approved Orserdu for postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. The approval was based on the P-III trial (EMERALD) results evaluating elacestrant vs SoC endocrine monotx. in 478 patients
- The trial met both 1EPs in all patients & whose tumors harbor ESR1 mutations (45% reduction in risk of progression or death) along with a significant PFS, m-PFS (8.6 vs 1.9mos.) whose tumors harbored ESR1 mutations & had been treated with a CDK4/6i for 12mos.
- ONA-XR (onapristone extended release), an oral progesterone receptor antagonist is being tested in the ongoing P-Ib/II trial (ELONA) to improve the activity of Orserdu in ESR1-mutated & wild-type metastatic breast cancer
Related Post: Insights+: The US FDA New Drug Approvals in December 2022
