On 4/23/09, Acorda Therapeutics (ACOR) announced the resubmission of its NDA for Fampridine-SR (Amaya) to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS) in response to a Refuse to File letter for the NDA issued by the Agency in late March. On 5/6/09, the FDA accepted the NDA with a priority review (six-month review) designation and a PDUFA action date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS.
On 10/14/09, the FDA Peripheral and Central Nervous System Drugs Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with MS and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use. The Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote (1 abstention) that these studies not be required prior to approval.
At the request of the FDA, the Committee discussed possible conditions for use, including for patients with renal impairment or history of seizure. Acorda has proposed a Risk Evaluation and Mitigation Strategy (REMS) program, which could include healthcare professional and patient education around appropriate use of Fampridine-SR.
On 7/1/09, ACOR announced an exclusive deal with Biogen Idec (BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales.
On 8/4/09, ACOR provided an update of adverse events (AE) for its three key MS studies with the only new AE being MS relapse (at 5.3% for the Fampridine-SR treated group vs. 3.8% for placebo). The imbalance for this AE was due to worsening of MS symptoms occurring after discontinuation of the drug.
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