Multiple Sclerosis Drug Lemtrada Gets FDA Nod

Lemtrada FDA-approved for patients with relapsing forms of MS.

Lemtrada^TM (alemtuzumab) has received FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS), Genzyme, the drug’s developer, announced.

The use of Lemtrada generally should be reserved for patients who have had an inadequate response to 2 or more drugs indicated for the treatment of MS because of its safety profile, the company noted.

The FDA approval of Lemtrada is based on 2 pivotal randomized Phase III open-label rater-blinded studies that compared treatment with Lemtrada and treatment with Rebif® (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were new to treatment (CARE-MS I) or who had relapsed while receiving previous therapy (CARE-MS II).

In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates. The difference observed in slowing disability progression did not reach statistical significance.

In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates. Accumulation of disability was significantly slowed in patients given Lemtrada vs interferon beta-1a.

Alemtuzumab is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab depletes circulating T and B lymphocytes after each treatment course. Lymphocyte counts then increase over time with a reconstitution of the lymphocyte population that varies for the different lymphocyte subtypes.

The Lemtrada label includes a boxed warning that notes a risk of serious, sometimes fatal autoimmune conditions and serious and life-threatening infusion reactions. The warning also notes that Lemtrada may increase the risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders.

Lemtrada is available only through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy), developed to ensure that access to the drug in the United States is only through certified prescribers, healthcare facilities, and specialty pharmacies and that patients are enrolled in the REMS program. The program is intended to inform health care providers and patients about the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support detection of these risks for 48 months after the last infusion.

“The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States,” said Dr Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option.”

Genzyme is a Sanofi company.