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FDA Updates for the Week of April 18, 2022


The FDA has approved a generic of Zavesca for Gaucher disease and has accepted applications for a supplement indication for Enhertu and a novel therapy for CKD-related anemia. The regulatory agency also issued a CRL for Teva’s schizophrenia drug.

The FDA approves Zavesca generic.

The FDA has granted final approval of Breckenridge Pharmaceutical’s abbreviated new drug application for miglustat capsules, a generic version of Janssen’s Zavesca, a therapy to treat mild-to-moderate type 1 Gaucher disease. The generic will be available in 100 mg strength and offered in a 90-count bottle. The company expects to launch miglustat capsules during the third quarter of 2022.

Gaucher is rare, genetic disorder caused by a mutation of the GBA gene, which impacts an enzyme that breaks down lipids. This causes a build up of lipids in the bone marrow, spleen and liver. Type 1 is the most common and symptoms include enlargement of the liver and spleen, anemia, lung disease and bone abnormalities.

Additionally, Breckenridge has launched two generic therapies. The first one is pencillamine capsules, a generic for Bausch Health’s Cuprimine, which is indicated to treat Wilson’s disease. The generic product was developed by Aggrega Pharma, and Breckenridge will market the product in its own label and offer the 250 mg strength in bottles of 100.

The company has also launched lacosamide tablets, a generic version of UCB’s Vimpat, a therapy to treat patients with primary generalized tonic-clonic seizures. The generic product was developed and will be manufactured by MSN Laboratories and marketed by Breckenridge in the United States. Lacosmide are available in 50 mg, 100 mg, 150 mg and 200 mg strengths, and contained in bottle of 60 or 500 tablets.

FDA accepts sBLA of Enhertu to treat metastatic lung cancer.

The FDA has accepted for review the supplemental biologics license application (sBLA) of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation. The application has also been granted priority review.

The Prescription Drug User Fee Act (PDUFA) date is during the third quarter of the 2022.

Enhertu is an antibody drug conjugate being jointly developed by Daiichi Sankyo and AstraZeneca. It is currently approved to treat patients with metastatic HER2 positive breast cancer and HER2 positive gastric or gastroesophageal junction adenocarcinoma.

The sBLA is based on data from the pivotal DESTINY-Lung01 phase 2 trial published in January 2022 in The New England Journal of Medicine and is supported by the phase 1 trial published in Cancer Discovery.

The FDA accepts NDA for novel therapy for CKD-related anemia.

The FDA has accepted GlaxoSmithKline’s new drug application (NDA) for daprodustat for the treatment of patients with anemia of chronic kidney disease (CKD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 1, 2023.

The application is based on results from two phase 3 trials—ASCEND-ND and ASCEND-D. These trials showed that daprodustat improved and/or maintained hemoglobin within the target level without increased major adverse cardiovascular events (MACE) in the intention-to-treat populations when compared with the standard of care, an erythropoietin stimulating agent, across both non-dialysis and dialysis patient settings.

The ASCEND program includes five phase 3 trials to assess the efficacy and safety profile of daprodustat for treating anemia of CKD across the disease pathway. The program enrolled more than 8,000 patients treated for up to 4.26 years.

FDA issues CRL for Teva’s schizophrenia drug.

The FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia. The FDA had accepted the application in August 2021 for TV-46000, which was developed by Teva Pharmaceutical and MedinCell.

The companies didn’t provide a reason for the CRL.

The regulatory application included phase 3 data from two pivotal studies: the RISE study and the SHINE. These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia. Data from the RISE study found that TV-46000 decreased the risk of relapse and increased chance of clinical stability versus placebo in patients with schizophrenia.

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