Federal regulators formally rejected Genzyme’s multiple sclerosis (MS) treatment over concerns about trial design and potentially serious side effects, the Cambridge-based drug maker said Monday.
Genzyme said it strongly disagrees with the U.S. Food and Drug Administration’s conclusion and plans to appeal the agency’s decision.
“We are extremely disappointed with the outcome of the review and the implications for patients in the U.S. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease,” said David Meeker, president and CEO of Genzyme, which has facilities in Northborough and Framingham.
The decision follows unfavorable reviews from FDA staff in November, who found Lemtrada increases 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 FDA asked Genzyme to conduct new clinical trials of Lemtrada using different designs and methods, which could take at least another year.
As part of French drug maker Sanofi’s $20.1 billion acquisition of Genzyme in 2011, Sanofi agreed to reward former Genzyme shareholders if Lemtrada achieved certain milestones. Genzyme announced Monday that it expects to miss a March 31 deadline for FDA approval of Lemtrada, which would have triggered one of those payments.
The announcement doesn’t appear to have hurt Sanofi’s stock price, which has climbed 1.2 percent from $52.80 to $53.41 since the market opened Monday.
Lemtrada has been approved for use in 30 other counties, including Australia, Canada and all of the European Union.
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