FDA advisers vote against Lexicon Pharma's add-on drug for type 1 diabetes (updated)

Lexicon Pharmaceuticals

31/10/2024 21:08

(Adds details in paragraphs 2 to 4)
       Oct 31 (Reuters) - Independent advisers to the U.S. Food
and Drug Administration on Thursday voted against recommending
Lexicon Pharmaceuticals'  LXRX.O  add-on treatment to insulin
therapy for managing blood glucose levels in adults with type 1
diabetes and chronic kidney disease.
     The decision by the independent experts marks another
setback for the company's years-long effort to market the drug.
    In early 2019, the FDA's advisory panel were divided over
whether to recommend approval of the drug chemically known as
sotagliflozin for type 1 diabetes. Shortly later, the FDA
declined to approve the drug. 
    Lexicon resubmitted the marketing application for the drug
in June 2024.
    The panel on Thursday voted 11-3 against the drug,
sotagliflozin.


 (Reporting by Sneha S K and Sruthi Narasimha Chari in
Bengaluru; Editing by Shailesh Kuber)
 ((Sneha.SK@thomsonreuters.com;))