Acordia's NDA generates Refusal to File letter from FDA

FDA cites two manufacturing concerns.

Upon its preliminary review, FDA determined that the NDA, submitted on 26 June 2017, was not sufficiently complete to permit a substantive review. FDA specified two reasons for the RTF: first, the date when the manufacturing site would be ready for inspection, and, second, 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.

Acordia will seek immediate guidance, including a Type 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, Acorda's President and CEO. “We remain confident in Inbrija’s data package and its promise as an important new therapy for people with Parkinson's disease. We see tremendous long-term value in its solid clinical profile, significant commercial opportunity and strong IP, and we remain focused on working to bring patients this important new therapy.”