Cambridge, Mass. Based Genzyme, a Sanofi subsidiary, announced May 30 that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of its proprietary drug Lemtrada (alemtuzumab) for treatment of relapsing forms of multiple sclerosis (MS). A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in Q4/2014
The resubmission of Lemtrada is based on data from the same clinical studies included in the original sBLA, and additionally provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month following constructive discussions with the agency.
According to a Multiple Sclerosis Society Of Canada (MSSoC) drug profile, Lemtrada (alemtuzumab) is a monotherapy delivered by intravenous infusion for management of relapsing-remitting multiple sclerosis in adults with active disease defined by clinical and imaging features, to reduce the frequency of clinical exacerbations (relapses) and to delay progression of physical disability.
The Society says clinical trial results from a study assessing the safety and efficacy of alemtuzumab compared with interferon beta 1a as a first line therapy in previously untreated people with relapsing-remitting MS, demonstrated treatment with alemtuzumab to be more effective at the end of the study period than treatment with interferon beta 1a.
Additionally, they say findings from a separate study assessing the safety and efficacy of alemtuzumab compared with interferon beta 1a in people with relapsing-remitting MS who have relapsed despite first-line treatment (interferon beta or glatiramer acetate) suggest that alemtuzumab was more effective in reducing relapse rate and disability progression compared with interferon beta 1a.
Interim results from the first year of the extension study of LEMTRADA were presented March 21, 2013 at the American Academy of Neurology meeting in San Diego, California.
The Phase III trials of LEMTRADA were randomized, two-year pivotal studies comparing treatment with LEMTRADA to Rebif (subcutaneous interferon beta-1a 44 mcg) in patients with relapsing-remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
The CARE-MS trials were Phase III, global, randomized clinical trials designed to evaluate whether the investigational MS therapy LEMTRADA could achieve meaningful efficacy and safety improvements over the approved, active comparator Rebif (subcutaneous interferon beta-1a 44 mcg), a standard treatment for relapsing-remitting MS.
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