FDA May Not Approve Genzyme's MS Drug, Citing Safety Issues

Today, U.S. Food and Drug Administration may rule on a new drug produced by Genzyme to treat multiple sclerosis.

But a preliminary federal FDA report released cited concerns about "multiple serious and potentially fatal safety issues" in patients given Sanofi's new multiple sclerosis drug Lemtrada.

Sanofi is the parent company of Genzyme, which has offices in Cambridge and Framingham. French drug maker Sanofi purchased Genzyme for $20.1 billion in 2011 based largely on anticipated sales of Lemtrada, reported the Worcester Business Journal

U.S. Food and Drug Administration staff  said Lemtrada increased the risk of autoimmune and thyroid diseases, including diabetes and cancer.

Europe approved the drug in September.

Annual Lemtrada sales worldwide is $752 million by 2018, according to forecasts compiled by Thomson Reuters Pharma.

Multiple sclerosis affects more than 2.1 million people globally. 

Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features. Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses.

The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

Genzyme's own press release in September said the "most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Serious autoimmune conditions can occur in patients receiving Lemtrada. A comprehensive risk management program will support early detection and management of these autoimmune events."

Last fall the FDA approved Genzyme's  once-daily oral treatment Aubagio to treat MS.

The drug, according to Genzyme, has been effective in reducing relapses, slowing the progression of physical disability and reducing the number of brain lesions as detected by MRI scans.