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FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.
On Aug. 29, 2017, Acorda Therapeutics, a biopharmaceutical company focused on neurological disorders, announced that FDA issued a Refusal to File (RTF) letter to the company regarding a new drug application (NDA) filed on June 26, 2017 for Inbrija (levodopa inhalation powder), an investigational treatment for Parkinson’s disease in patients taking a carbidopa/levodopa regimen.
FDA determined in a preliminary review that the NDA was not sufficiently complete to permit a substantive review. The agency specified two reasons why it issued the RTF. The first involved the date when the manufacturing site would be ready for inspection. The second was a question it had 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.
Acorda said in a company press release that it will seek immediate guidance, including a Type A meeting with FDA, to respond to the issues. The company believes these issues are addressable, and it will seek clarification about what additional information will be required. FDA has not requested or recommended additional clinical efficacy or safety studies.
“We will work with FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” said Ron Cohen, MD, Acorda's president and CEO, in the press release. “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 [intellectual property], and we remain focused on working to bring patients this important new therapy.”
Source: Acorda Therapeutics