FDA Slams Genzyme's MS Drug

FILE PHOTO Genzyme may be based in Cambridge, but the company has more than 2,000 employees in MetroWest, including some at this building in Framingham.

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U.S. regulators said Friday that the risks from a multiple sclerosis (MS) drug developed by Cambridge-based Genzyme might outweigh its benefits and recommended against the drug’s approval.

Staff at the U.S. Food and Drug Administration staff found that Lemtrada increased the risk of autoimmune and thyroid diseases such as diabetes and cancer while failing to control for bias in its demonstration of clinical benefits.

“Multiple serious and potentially fatal safety issues have been reported in patients treated with (Lemtrada) for MS,” FDA drug reviewer Dr. Evelyn Mentari wrote.

An advisory panel will meet Wednesday and consider whether to recommend Lemtrada for sale in the United States. Genzyme, which has facilities in Northborough and Framingham, was purchased by French drug maker Sanofi for $20.1 billion in 2011 based largely on anticipated sales of Lemtrada.

FDA reviewer Dr. John Marler said results from clinical trials of Lemtrada might have been skewed by Genzyme’s decision to not keep secret which patients were taking the medicine.

Genzyme spokesman Bo Piela said the company was unable to keep the test entirely blind because of differences in how Lemtrada and the drug with which it was compared were administered.

“Our company is confident that Lemtrada offers an important step forward in the way physicians and patients will think about treating multiple sclerosis,” Piela said in a statement. “There are, of course, issues that will be considered by the advisory committee and we look forward to our discussion with them.”

Genzyme received approval Sept. 17 to market Lemtrada in the European Union. The active ingredient in Lemtrada – alemtuzumab – was approved by the FDA in 2001 to treat a certain form of leukemia, but Marler said MS patients will likely be exposed to the drug for longer periods due to the slow progression of the disease.

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