Acorda Therapeutics has announced that the PDUFA date for review of its NDA for the Inbrija levodopa DPI for the treatment of symptoms during OFF periods in Parkinson’s disease patients has been changed from October 5, 2018 to January 5, 2019.
The company said that the FDA extended the review period because Acorda’s submission in response to a request by the agency for additional CMC information is considered a major amendment to the application, necessitating additional review time.
An 505(b)(2) NDA for Inbrija was initially submitted in June 2017. Two months later, the FDA issued a refuse to file letter saying that the application lacked sufficient information, and Acorda resubmitted the NDA in December 2017. The agency accepted that application in February 2018.
Acorda also submitted a marketing application for Inbrija to the EMA in March 2018.
Acorda President and CEO Ron Cohen said, “We look forward to continuing our constructive dialogue with FDA. We remain committed to bringing Inbrija to approval for people with Parkinson’s who experience OFF periods, which are highly disruptive and in need of new therapeutic options.”
Read the Acorda Therapeutics press release.
