FDA Rejects Acorda’s NDA Over ManufacturingBy
Acorda Therapeutics, a New York-headquartered biopharmaceutical company, has received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for its Parkinson’s drug, Inbrija.
Upon preliminary review, the FDA determined that the NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review. The FDA specified two issues for the RTF: (1) the date when the manufacturing site would be ready for inspection and (2) questions 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 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.
Inbrija is an investigational treatment for symptoms of off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
Source: Acorda Therapeutics