FDA accepts Lexicon's heart failure resubmission; Bristol Myers buys out mavacamten royalties
Just two weeks after the FDA again denied Lexicon Pharmaceuticals’ attempt to overturn a CRL in type 1 diabetes, the Texas biotech said the agency has accepted the drug’s resubmission for heart failure.
A decision date is slated for sometime in May 2023. The regulator will consider two Phase III trials, one in which worsening heart failure sent type 2 diabetes patients into the hospital (SOLOIST-WHF) and another that includes patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease (SCORED). In total, sotagliflozin has been tested in 14 Phase III trials in about 20,000 people.
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