Genzyme MS Drug Has Setback
Genzyme, a biotechnology company with operations in MetroWest, has suffered a setback in its plans to sell its multiple sclerosis (MS) drug in the United States.
According to Genzyme, which is based in Cambridge, it received a letter from the U.S. Food and Drug Administration (FDA) in response to its biologics license application it filed in June for Lemtrada, which would be used for the treatment of relapsing MS.
Genzyme said that, in the "refuse to file" letter, the FDA has requested that the firm modify the presentation of its data sets "to enable the agency to better navigate the application" but said the FDA had not asked for additional data or further studies. Genzyme said it will work with the FDA to meet its requests in the coming weeks and hopes to resubmit the application as soon as possible.
Lemtrada is being developed in collaboration with Bayer HealthCare. A marketing authorization application for the drug was also submitted to the European Medicines Agency, roughly the European Union's FDA equivalent, in June. That application has been accepted and the review process is underway.
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