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.
And alemtuzumab will only be available through a restricted distribution program that will require prescribers, pharmacies, and patients to be certified. The intent is to “educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion,” the statement said.
Alemtuzumab is unusual among MS drugs in several respects. It was sold for many years as Campath for treating certain leukemias. In MS, it is administered by IV infusion in two annual cycles, the first lasting 5 days and the second 3 days. Its target is the CD52 protein on the surfaces of T and B cells. The two treatment cycles temporarily deplete these cells. Their subsequent re-population is marked by a transformation in immune responsiveness, such that the autoimmune attack on myelin fibers in the nervous system is shut down or at least reduced in most patients.
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