Lemtrada alemtuzumab regulatory update

FDA approved a resubmitted sBLA for Lemtrada alemtuzumab from Sanofi’s Genzyme Corp. unit to treat adults with relapsing forms of multiple sclerosis. The agency approved the humanized mAb against CD52 with a REMS and required that it be sold under a restricted distribution program. Lemtrada’s label carries a boxed warning noting the risks of potentially fatal autoimmune conditions, serious infusion reactions and malignancies, including thyroid cancer, melanoma and lymphoproliferative disorders.

FDA based its approval on the Phase III CARE-MS I and CARE-MS II studies. Patients receiving Lemtrada in CARE-MS I showed significantly reduced relapse rates compared to subcutaneous Rebif interferon beta-1a from Merck KGaA (Xetra:MRK, Darmstadt, Germany), but the drug missed the study’s co-primary endpoint of time to 6-month sustained accumulation of disability (SAD). In CARE-MS II, Lemtrada met the co-primary endpoints of significantly reducing relapse rate at 2 years and the rate of 6-month SAD compared to Rebif. ...