Acorda Therapeutics Receives Refusal to File Letter from FDA for Inbrija New Drug Application

Acorda Therapeutics (ACOR) that it received a refusal to file (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for Inbrija.

Inbrija is an investigational treatment for patients with Parkinson’s disease taking a carbidopa/levodopa regimen.
Tne FDA determined that the NDA, submitted in June, was not sufficiently complete to permit a substantive review. The two reasons for the RTF were, the date when the manufacturing site would be ready for inspection, and, a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission, which was not part of the basis for the RTF.

The company said it will seek immediate guidance, including a meeting with the FDA to respond to the issues, which it believes are addressable, and to seek clarification of what additional information will be required. The FDA has not requested or recommended additional clinical efficacy or safety studies.

“We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” said Ron Cohen, CEO of Acorda. “We remain confident in Inbrija data package and its promise as an important new therapy for people with Parkinson’s disease.”

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