Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other EventsItem 8.01Other Events
Acorda Therapeutics, Inc. (the “Company”) announced today an update on the Refusal to File (RTF) letter that it received from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for INBRIJA™ (CVT-301, levodopa inhalation powder). The Company has engaged in a constructive dialogue with the FDA to determine the most efficient path forward to resubmitting the INBRIJA NDA. Based on these interactions, Acorda believes it can resubmit without a Type A meeting, and therefore will not request such a meeting.
The Company reiterated that the issues raised in the RTF are addressable and that the FDA has not requested or recommended additional clinical efficacy or safety studies. Acorda plans to resubmit the NDA as soon as possible.
About Acorda Therapeutics,Inc. (NASDAQ:ACOR)
Acorda Therapeutics, Inc. is a biopharmaceutical company. The Company is engaged in the identification, development and commercialization of therapies that restore function and recovers the lives of people with neurological disorders. Its commercial products include Ampyra, Fampyra, Zanaflex Capsules and a generic version of the capsules, Zanaflex tablets and Qutenza. Its research and development programs include CVT-301, Dalfampridine, Plumiaz, Neuregulin Program, Remyelinating Antibodies Program, CVT-427 and Chondroitinase Program. Its Ampyra is an oral drug for the treatment to improve walking in patients with multiple sclerosis. Zanaflex Capsules and tablets are used as short-acting drugs for the management of spasticity. Qutenza is a dermal patch for the management of neuropathic pain associated with post-herpetic neuralgia. Its pipeline of neurological therapies addresses a range of disorders, including Parkinson’s disease, chronic post-stroke walking deficits and migraine.
