Acorda was hoping to secure an approval for Inbrija in October, but on Thursday, the FDA moved its decision deadline back to January. (Pixabay
Acorda Therapeutics just got its second bad-news blow of the week. First, it lost an appeal that could have fended off generic copies of its primary sales generator, Ampyra. And now, instead of approving the Parkinson's drug Inbrija just in time to give Acorda a lifeline, the FDA pushed back its decision to January.
The FDA had originally expected to decide on Inbrija by Oct. 5, but the agency extended that deadline to Jan. 5 to review Acorda's recent submissions on “chemistry, manufacturing and controls.”
The delay comes at a terrible time for Acorda. Earlier this week, a federal appeals court upheld a lower court's decision to invalidate patents on its multiple sclerosis drug Ampyra, which pulled in $150.3 million of the company's $153.3 million in second-quarter sales. With the decision, two generic makers should be able to enter the market, Jefferies analyst Michael Yee wrote, ready to take a bite out of Acorda's share.
In a statement, Acorda CEO Ron Cohen said his company looks “forward to continuing our constructive dialogue with FDA” and remains committed to Inbrija. The company has said the Parkinson’s drug could pull in more than $800 million.
All told last year, Ampyra generated $542 million for Acorda. After a patent loss in district court, the company laid off 100 staffers and moved to advance Inbrija. Acorda has guided for Ampyra sales of $300 million to $350 million this year.
Acorda's shares were down about 18% on Thursday morning ahead of the market open.
https://www.fiercepharma.com/pharma/after-ampyra-setback-acorda-s-much-needed-inbrija-hits-a-snag-at-fda
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