FDA Approves New Treatment Option for MS

The FDA has approved Lemtrada (alemtuzumab) for the treatment of certain relapsing forms of multiple sclerosis (MS) in patients with inadequate response to 2 or more MS therapies.

Lemtrada is administered in 2 annul doses: a daily injection on 5 consecutive days in the first course, and 3 consecutive days in the second course, 12 months later.
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The drug is only available through the Lemtrada Risk Evaluation and Mitigation Strategy distribution program, ensuring that only certified prescribers and healthcare facilities receive the drug. The program is intended to educate prescribers and patients about the risk of serious, possibly fatal conditions related to the use of the drug, including thyroid cancer, melanoma, and lymphoproliferative disorders.

Approval of Lemtrada was based on 2 phase 3 trials that compared Lemtrada to subcutaneous interferon beta-1a. The drug works by targeting CD52, a protein found on T and B cells—the cells thought to be responsible for damaging inflammation in MS.

Some side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, insomnia, herpes infection, thyroid gland disorder, diarrhea, back pain, thyroid disease, autoimmune cytopenias, and pneumonitis.

—Michael Potts

Reference:

1. Genzyme. Genzyme’s lemtrada approved by the FDA [press release]. November 14, 2014. http://news.genzyme.com/press-release/genzymes-lemtrada-approved-fda. Accessed November 17, 2014.