The U.S. Food and Drug Administration have granted marketing approval for Genzyme’s alemtuzumab (Lemtrada) for the treatment of relapsing remitting multiple sclerosis after initially rejecting the therapy nearly a year ago.
However, the approval does not come without strings. Because of the serious risks associated with Lemtrada, the therapy has been recommended as a third-line treatment for patients who have not been responsive to two or more drugs meant for the treatment of MS. The Lemtrada label will also include a boxed warning for serious and sometimes fatal autoimmune conditions, serious infusion reactions and an increased risk of malignancies.
Additionally, Lemtrada will only be made available through a restricted distribution program called Lemtrada REMS (Risk Evaluation and Mitigation Strategy) to ensure that access to Lemtrada is only given through certified prescribers, pharmacies, and patients in order to make providers and patients more aware of the serious safety risks associated with the drug. Lemtrada, which was originally used to treat leukemias under the brand name Campath, is administered via IV infusion in two annual cycles, the first for five days and the second 12 months later for three days. The REMS program will help enforce a 48-month monitoring period for risks after the last infusion.
Lemtrada targets the CD52 protein on the surfaces of T and B cells, temporarily depleting them. The repopulation of the cells transforms immune response and subsequently shuts down or reduces the autoimmune attack on myelin fibers in the nervous system. In trials, Lemtrada produced significant declines in relapse rates compared to interferon-beta-1a, however trial design was one of the main reasons for the FDA’s initial rejection.
Lemtrada was previously approved in Canada, Europe, and Australia.
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.