Acorda announced its receipt of a Refusal-to-File (RTF) letter today. The firm explained the US Food and Drug Administration (FDA) had asked when its manufacturing site would be ready for inspection.
The New York, US firm also said the agency had asked it to submit drug master production records. It also said the FDA had requested additional information at resubmission, which was not part of the basis for the RTF.
Acorda said it “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.”
It also stressed the FDA has not requested or recommended additional clinical efficacy or safety studies.
In July, Acorda CEO Ron Cohen was positive about Inbrija’s prospects. He told analysts that launch preparations were underway and predicted peak net sales in the US alone of more than $500m. He also said the firm plans to file the drug with the European Medicines Agency (EMA) before the end of the year.
Also during the call - in reference to Inbrija - Cohen said: "We're preparing separately on manufacturing pre-approval inspection, is a key item, and so we're drilling on that over and over and over so that we will be prepared for pre-approval inspections."
Acorda did not respond to a request for comment about the RTF letter.
Delivery tech
Inbrija is being developed to treat “off” periods in people with Parkinson’s disease who are taking a carbidopa/levodopa regimen.
Acorda acquired the drug when it bought Civitas Therapeutics in 2014.
The drug – previously known as CVT-301 - is based on Civitas' proprietary Arcus technology, which is an aerosol delivery system that allows precise delivery of large quantities of drug via inhalation.
Medicines based on the technology are administered using a breath-actuated inhaler which, unlike other pulmonary systems, does not require carrier particles or supplemental energy to disperse.