U.S. FDA declines to approve Supernus' drug-device combination for Parkinson's disease (updated)

Acorda Therapeutics

08/04/2024 13:21

(Adds details on FDA's response in paragraph 2)
       April 8 (Reuters) - The U.S. Food and Drug
Administration (FDA) declined to approve Supernus
Pharmaceuticals'  SUPN.O  drug-device combination to treat
movement-related symptoms of Parkinson's disease, the drugmaker
said on Monday.  
    The company said U.S. Food and Drug Administration's
so-called "complete response letter" indicated the review cycle
for the application was complete, but the treatment was not
ready for approval in its present form.
    The decision is another hurdle in the company's years-long
effort to market the pump-based treatment, which continuously
delivers apomorphine under the skin compared to the more common
injection form used to control symptoms.
    One of the areas flagged for additional review is product
quality, for which the company has submitted additional data.

 (Reporting by Puyaan Singh in Bengaluru; Editing by Shinjini
Ganguli)
 ((Puyaan.Singh@thomsonreuters.com;))