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FDA Rejects Lemtrada (Alemtuzumab) for Treatment of Multiple Sclerosis

Benefits don’t outweigh risks (December 30)

The FDA has rejected a supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab), a monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (MS).

In its Complete Response Letter (CRL), the agency stated that the drug’s developers (Sanofi/Genzyme) failed to submit evidence from adequate and well-controlled clinical trials demonstrating that the benefits of Lemtrada outweigh its serious adverse effects. The FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada.

The drug’s clinical development program included two pivotal randomized phase III studies comparing alemtuzumab with high-dose subcutaneous interferon (IFN) beta-1a (Rebif, EMD Serono/Pfizer) in patients with relapsing MS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

In CARE-MS I, alemtuzumab was significantly more effective than IFN beta-1a at reducing annualized relapse rates; however, the difference observed in slowing the progression of disability did not reach statistical significance. In CARE-MS II, alemtuzumab was significantly more effective than IFN beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients treated with alemtuzumab compared with IFN beta-1a.

The most common side effects of treatment with alemtuzumab include infusion-associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia, and leukopenia. Serious autoimmune conditions can occur in patients receiving the drug.

Source: Sanofi; December 30, 2013.

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