Lemtrada Wins FDA Approval for MS but Not Without Risks

Lemtrada will include a boxed warning for serious risks including autoimmune conditions, infusion reactions, and malignancies.

Overcoming an initial rejection by the FDA, alemtuzumab (Lemtrada) was given marketing approval late Friday for treatment of relapsing-remitting multiple sclerosis but “generally” as a third-line treatment, its manufacturer said.

The approval also comes with a requirement for a boxed warning about “serious, sometimes fatal autoimmune conditions,” severe infusion reactions, and the possibility of increased risk of certain cancers, according to the announcement from Sanofi’s Genzyme unit.

Alemtuzumab will only be available through a restricted distribution program that will require prescribers, pharmacies, and patients to be certified.

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