Acorda Therapeutics is celebrating the news that advisors to the US Food and Drug Administration have voted to recommend approval for fampridine as a treatment to improve walking in multiple sclerosis patients.
The agency’s Peripheral and Central Nervous System Drugs Advisory Committee has voted 12 to one that clinical data presented for fampridine-SR 10mg twice-daily demonstrated “substantial evidence of effectiveness as a treatment to improve walking in people with MS. The panelists voted 10 to two (ie with one abstention) that it is “clinically meaningful and can be safe for use”.
The committee also recommended by a vote of 12 to one that Acorda be required to evaluate the effects of doses lower than 10mg twice daily, but by a 10 to two vote (again with one abstention) that these studies do not have to be done prior to approval. They are concerned about allowing use for patients with renal impairment or history of seizure, but Acorda says it has proposed a risk evaluation and mitigation strategy programme relating to appropriate use of fampridine-SR.
The panel’s decision is particularly welcome seeing as a couple of days ago, FDA staffers claimed that the oral sustained-release compound “has a very limited effect”. However those concerns seem to have been put to one side and Acorda chief executive Ron Cohen said the company was pleased with the outcome of the PCNSD meeting, describing it as “an important milestone”.
The FDA is scheduled to make its final decision by October 22 and while Acorda initially proposed the brandname Amaya, it has been reported that the company has now plumped for Ampriva. In July, Biogen Idec signed a deal to acquire the rights to the drug outside the USA.
