Acorda Therapeutics has received a refusal to file letter from the FDA in response to its NDA for Inbrija (CVT-301) inhaled levodopa for the treatment of OFF periods in Parkinson’s disease patients, the company said. Acorda submitted the 505(b)(2) NDA in June 2017.
According to the company, the FDA letter said that the NDA lacked sufficient information for review, including information about when the manufacturing facility would be available for inspection and about the drug master production record. The agency did not request any additional clinical study data.
Acorda President and CEO Ron Cohen said, “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. 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.”
Read the Acorda press release.
