Genzyme to reapply for MS drug approval
FILE PHOTO
The exterior of the Genzyme facility in Framingham
Genzyme plans to resubmit its application to U.S. regulators for its multiple sclerosis (MS) treatment, the Cambridge-based drug maker said Monday.
Genzyme said it has had constructive discussions with the U.S. Food and Drug Administration (FDA) after it rejected Lemtrada in December over concerns about trial design and potentially serious side effects. Genzyme, which has operations in Framingham and Northborough, said it will reapply by the end of June and forgo an appeal of the FDA decision, which the company was intending to do in December.
The FDA criticized the drug for increasing the risk of autoimmune and thyroid diseases such as diabetes and cancer while failing to control for bias in its demonstration of clinical benefits. The resubmitted application will address those specific issues, Genzyme said.
The regulatory verdict was criticized in a March letter to the FDA by 70 physicians, who argued that it was not possible to keep the test entirely blind since Lemtrada and comparable treatment are administered differently. The MS specialists argued that Lemtrada was unique in showing superiority to an active competitor, which few other MS drugs have accomplished.
Lemtrada has been approved for use in more than 30 countries, including Australia, Canada, the European Union, Mexico and, most recently, Brazil.
Genzyme was purchased by French drug maker Sanofi for $20.1 billion in 2011, based largely on anticipated sales of Lemtrada.
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