Insights+: The US FDA New Drug Approvals in November 2021
The US FDA has approved 6 NDAs and 1 BLAs in 2021, leading to treatments for patients and advances in the health care industry
The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 68 novel products in 2021
Additionally, last year in 2020, the US FDA has approved 121 novel products. PharmaShots has compiled a list of a total of 7 new drugs approved by the US FDA in November 2021
Tris Pharma’s Dyanavel XR (amphetamine) Receives US FDA’s Approval for the Treatment of ADHD
Published: Nov 05, 2021| Tags: Tris Pharma, Dyanavel XR, amphetamine, US, FDA, Approval, ADHD
- The approval was based on the P-III study to evaluate Dyanavel XR tablets vs PBO in patients aged 6 to 12yrs. with ADHD
- The results showed that patients treated with Dyanavel XR ER tablets were bioequivalence to Dyanavel XR ER oral suspension, improvement in ADHD symptom within 1hrs., improvement in mean PERMP-T scores across all post-dose time points measured. Patients with Dyanavel XR oral suspension can switch to the same dose of Dyanavel XR tablets
- In an exploratory study, Dyanavel XR oral suspension showed an improvement of ADHD symptoms in 30 min. after dosing. Dyanavel XR is a federally controlled substance (CII) & are expected to be available in Q1’22
Published: Nov 8, 2021| Tags: Eton, Azurity, Eprontia, topiramate, US, FDA, Approval, Seizures, Migraines
- The US FDA has approved Eprontia (25mg/mL) oral solution as a monothx for partial-onset or primary generalized tonic-clonic seizures. The oral solution is also approved as an adjunctive treatment for the same indication or seizures associated with Lennox-Gastaut syndrome in patients aged ≥2yrs. along with treatment of migraine in patients aged ≥12 yrs.
- Azurity will lead the commercialization of the product & is expected to be available at the end of 2021
- Eprontia is the 1st oral liquid formulation of topiramate to be approved by the US FDA. Eton will receive a $5M milestone upon the commercial launch of Eprontia & is eligible to receive commercial milestones along with royalties
Published: Nov 18, 2021| Tags: Onco360, BESREMi, ropeginterferon alfa-2b-njft, US, FDA, Approval, Polycythemia Vera
- The approval is based on the (PEGINVERA) study to evaluate BESREMi in patients with Polycythemia Vera. BESREMi is manufactured by PharmaEssentia
- The results showed that patients treated with BESREMi achieved a CHR (61%) during the treatment period defined as hematocrit <45% & no phlebotomy in the preceding 2mos., platelets < 400 x 109/L and leukocytes < 10 x 109/L, normal spleen size assessed by ultrasound and absence of thromboembolic events, m-OS was ~20yrs.
- BESREMi was approved for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic, and infectious disorders
Published: Nov 19, 2021| Tags: BioMarin, Voxzogo, vosoritide, US, FDA, Approval, Achondroplasia
- The approval was based on the P-III study and the open-label extension to evaluate Voxzogo vs PBO in 121 children aged 5 to 14.9yrs. with achondroplasia. Following the completion of the 52wks. P-III study, 58 patients were enrolled into an open-label extension
- The results showed an improvement in AGV @2yrs of follow-up, 8 (13%) of 60 patients treated with Voxzogo had a total of 11 events of transient decreases in blood pressure compared to 3 (5%) of 61 patients on PBO @52wks. treatment period
- The therapy is expected to be available in the US in December while BioMarin will initiate the promotion of Voxzogo imminently. In Aug 2021, Voxzogo received the EC approval for the same indication
Published: Nov 24, 2021| Tags: Takeda, Livtencity, maribavir, US, FDA, Approval, Post-Transplant, Cytomegalovirus Infection
- The approval is based on the P-III TAK-620-303 (SOLSTICE) trial evaluates the efficacy & safety of Maribavir (400mg, qd) vs IAT in a ratio (2:1) in 352 HCT and SOT recipients aged 12yrs. with CMV infection refractory with/out resistance- to one or a combination of the conventional antiviral therapies. The therapy will be available shortly
- The study showed that the proportion of patients who achieved confirmed CMV DNA level
- Livtencity is an orally bioavailable anti-CMV compound & is the 1st antiviral agent that targets and inhibits the pUL97 protein kinase and its natural substrates
Published: Nov 26, 2021| Tags: Aadi Bioscience, Fyarro, US, FDA, Approval, Malignant Perivascular Epithelioid Cell Tumor
- The approval is based on the P-II (AMPECT) trial to evaluate the efficacy of Fyarro (IV) in 34 adults aged ≥18yrs. with LA unresectable or metastatic malignant PEComa
- The results showed ORR (39%) as assessed by independent review & 2 patients achieved a CR after prolonged follow up; m-DoR has not been reached with a median follow-up of 36 mos., 92% & 67% had a response through ≥6 & ≥12mos. & 58% had a response through ≥2yrs.
- Fyarro is an mTOR inhibitor & the 1st approved therapy indicated for advanced malignant in adults. The company plans to launch Fyarro in Q1’22
Published: Nov 29, 2021| Tags: On Target Laboratories, Cytalux, pafolacianine, US, FDA, Approval, Ovarian Cancer
- The US FDA has approved Cytalux for adult patients with ovarian cancer as an adjunct treatment for intraoperative identification of malignant lesions
- Cytalux is the first targeted fluorescent imaging agent that irradiates ovarian cancer intraoperatively & allows to detect of more cancer for removal
- The therapy received Priority Review, FTD, and ODD from the US FDA. Additionally, Cytalux is being investigated in lung cancer in a P-II trial which is under FT designation
Related Post: Insights+: The US FDA New Drug Approvals in October 2021
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com
