Acorda Therapeutics, Inc received a refuse to file letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).
The FDA has raised what it termed 'format issues' regarding the eCTD (electronic) submission, requesting that some of the data in the NDA be reformatted, as well as requesting that some additional supporting information be included in the filing. The FDA has not requested or recommended additional clinical or other studies.
"We are surprised by this development," stated Ron Cohen, president and CEO of Acorda Therapeutics, "We plan to address the issues raised in this letter with FDA expeditiously as we believe Fampridine-SR is potentially an important, first in class treatment option for people suffering with MS."
The company plans to request a meeting with FDA as soon as possible to discuss its comments on the NDA filing.
Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The company's marketed products include Zanaflex Capsules (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.