PARIS (dpa-AFX) - Genzyme of Sanofi (SNY, SNYNF.PK) announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration, or FDA, and a marketing authorization application to the European Medicines Agency, or EMA, seeking approval of LEMTRADA (alemtuzumab) for treating relapsing multiple sclerosis, or RMS.
Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare. The company stated that its clinical development program for LEMTRADA included two Phase III studies in which results for LEMTRADA were superior to Rebif (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate. Besides, some patients with pre-existing disability treated with LEMTRADA in the CARE-MS II trial were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif.
According to Genzyme, the regulatory submissions for LEMTRADA include two-year controlled efficacy and safety data from both treatment-naïve patients and those who relapsed while on therapy, with greater than five years of safety follow-up. Common adverse events associated with alemtuzumab were consistent across the Phase III program and included infusion-associated reactions and infections, which were generally mild to moderate in severity. Autoimmune adverse events were observed in some patients with cases being detected early through a monitoring program and managed using conventional therapies, the company noted.
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