The FDA is warning consumers about the risk of rare but serious cases of stroke and tears in the lining of arteries in the head and neck associated with multiple sclerosis drug Lemtrada, chemically known as Alemtuzumab. These problems can lead to permanent disability and even death.
Lemtrada, developed by Genzyme, a Sanofi company, received FDA approval for the treatment of relapsing forms of multiple sclerosis in November 2014. The drug was launched in the U.S. in December 2014, with a boxed warning regarding the risk of autoimmunity, infusion reactions, and malignancies. The label was updated last October to include the risk of acute acalculous cholecystitis (acute inflammation of the gallbladder in the absence of gallstones).
Lemtrada brought home annual sales of 474 million euros for Sanofi in 2017, and quarterly sales of 99 million euros in the third quarter of 2018.
Alemtuzumab, under brand name Campath, was approved in May 2001 to treat a type of cancer called B-cell chronic lymphocytic leukemia (B-CLL). In order to prevent the off-label use of Alemtuzumab, Sanofi had withdrawn the drug from the U.S. and EU markets in 2012.
The U.S. regulatory agency noted that the Campath drug label will also be updated to include the risks regarding stroke and tears in the lining of arteries in the head and neck.
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