The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions it made in response to requests from the FDA for additional data on chemistry, manufacturing & controls.
ACOR shares were trading at $16.20 apiece in mid-morning activity today, down -12.4%.
“We look forward to continuing our constructive dialogue with FDA,” Acorda’s president & CEO Dr. Ron Cohen said in prepared remarks. “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.”
Acorda’s inhaled product has succeeded in late-stage Phase III safety and efficacy trials, helping to improve motor function in people with Parkinson’s disease.
But the company faced a major regulatory setback last year when the FDA issued a ‘refuse to file’ letter to the company, signaling that it would not review Acorda’s Inbrija application.
The FDA accepted Acorda’s resubmitted application in February this year.
“The people who are in this industry, they get what it’s about. They understand that developing a new drug successfully is one of the hardest things that a group of human beings can do,” Cohen told Drug Delivery Business News earlier this year. “It is so incredibly complex and there are so many ways to get stalled out or have setbacks.”