A panel of FDA experts had no trouble overcoming the concerns of regulators when they voted to approve Acorda Therapeutics' new drug to improve the ability of multiple sclerosis patients to walk. The experts voted 12 to one in its favor, clearing the way to a final decision on Amaya, or fampridine-SR. And investors loved every bit of it, boosting Acorda's shares by 48 percent this morning.
FDA staffers had unnerved investors along with analysts on Friday when they raised their concerns about the clinical validity of a therapy that raised the risk of seizures while improving walking ability. Adam Feuerstein notes over on TheStreet, though, that the agency had also included an odd disclaimer that the views expressed in the staff review didn't necessarily reflect the agency's opinion. And the columnist adds that it's unlikely that the FDA will meet its October 22 decision deadline for a final decision, given the timing of the vote and prospective talks about labeling and a risk-management plan.
"People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS," said Ron Cohen, M.D., Acorda Therapeutics president and CEO. They're not the only biotech company to breathe a sigh of relief. Biogen Idec had licensed the drug earlier this year in a deal worth a total of $510 million.
- check out the Acorda's release
- here's the story from TheStreet