The FDA rejected Lexicon Pharmaceuticals/Sanofi’s sotagliflozin a second time as a treatment for type 1 diabetes on 12/2/2019. Previously, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had a split decision (8-8) on sotagliflozin on whether to recommend approval of the drug as an add-on to insulin therapy in patients with type 1 diabetes in January 2019. Some members of the committee expressed concern regarding the increased risk for diabetic ketoacidosis with the drug. The FDA rejected sotagliflozin as a treatment for type 1 diabetes on 3/22/2019. The EMA approved sotagliflozin in April 2019 for the treatment of Type 1 Diabetes. Sanofi ceased participation in the development of sotagliflozin in July 2019 after the results from 3 Phase III type 2 diabetes trials were announced.
The FDA rejected RVT-802 on 12/5/19 due to manufacturing issues.
Immunomedics resubmitted the BLA for sacituzumab govitecan for the treatment of resistant metastatic triple-negative breast cancer.
ViiV Healthcare submitted an NDA for fostemsavir in December 2019. Fostemsavir was bought from BMS in December 2015.
The FDA has placed a partial clinical hold on four of Clementia’s palovarotene trials [(two fibrodysplasia ossificans progressiva (FOP) studies and two osteochondroma studies)] due to reports of early growth plate closure in patients with FOP in patients under the age of 14.
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