Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of sotagliflozin for the treatment of heart failure. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
“The resubmission of our NDA places us a step closer to the possibility of bringing this innovative new investigational treatment to heart failure patients,” said Lonnel Coats, Lexicon’s chief executive officer. “We believe sotagliflozin’s dual SGLT1 and SGLT2 mechanism and the data from our SOLOIST-WHF and SCORED Phase 3 trials address important areas of need in the treatment of heart failure. We look forward to working closely with the FDA during the review process.”
The NDA submission is supported by the results from the Phase 3 SOLOIST-WHF clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
https://finance.yahoo.com/news/lexicon-resubmits-drug-application-sotagliflozin-120000913.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.