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(RTTNews) – FDA warns consumers of the risk of rare but serious cases of cerebrovascular accidents and tears in the lining of the arteries of the head and neck associated with the drug Lemtrada, known by the chemical name of alemtuzumab. These problems can lead to permanent disability and even death.
Lemtrada, developed by Genzyme, a Sanofi group company, was approved by the FDA for the treatment of relapsing forms of multiple sclerosis in November 2014. The drug was launched in the United States 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 reported an annual turnover of 474 million euros to Sanofi in 2017 and a quarterly turnover of 99 million euros in the third quarter of 2018.
Alemtuzumab, under the brand name Campath, was approved in May 2001 for the treatment of a type of cancer called B-cell chronic lymphocytic leukemia (B-CLL). In order to prevent the misuse of Alemtuzumab, Sanofi removed the drug from the US and European markets in 2012.
The US regulator has indicated that the Campath drug label will also be updated to include risks from strokes and tears in the lining of the arteries of the head and neck.
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