Genzyme MS Drug Gets FDA Approval
The U.S. Food and Drug Administration (FDA) has approved a Genzyme drug for patients with relapsing forms of multiple sclerosis (MS), the company announced.
Genzyme, which has facilities in MetroWest, said the once-daily oral treatment Aubagio has been effective in reducing relapses, slowing the progression of physical disability and reducing the number of brain lesions as detected by MRI scans.
The ongoing clinical development program of Aubagio, Genzyme's first MS treatment, involves more than 5,000 patients in 36 countries and is among the largest for any MS therapy, with some patients having been treated for up to 10 years, Genzyme said.
"Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly," said Dr. Aaron E. Miller, medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center. "The FDA's approval of Aubagio … is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease."
Marketing applications for Aubagio are under review by the FDA's European counterpart, the European Medicines Agency, and other regulatory authorities.
The good news for Cambridge-based Genzyme comes less than a month after it suffered a setback for another MS treatment, Lemtrada. The FDA had told the company that it needed data presentation to be clearer in order to be considered for a biologics license. Genzyme said it would work to address the FDA's concerns and quickly reapply.
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