NAPSR News: FDA Approves Genzyme’s Lemtrada to treat Multiple Sclerosis

WASHINGTON - Nov. 17, 2014 - PRLog -- Genzyme’s MS therapy, Lemtrada (alemtuzumab) has been approved by the U.S. Food and Drug Administration to treat patients with relapsing forms of multiple sclerosis (MS). The drug is intended to treat individuals who are unresponsive other forms of MS treatments.

“Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker.“Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment.”

Lemtrada’s approval is based on two pivotal randomized Phase III open-label rater-blinded studies which compared it to EMD Serono’s to Rebif^®(high-dose subcutaneous interferon beta-1a) involving 1,500 patients.  Clinical data revealed Lemtrada was considerably more effective than Rebif in patients with relapsing remitting MS who were new to treatment  (CARE-MS I). The therapy was also successful in reducing annualized relapse rates and slowing the disability progression compared to interferon beta-1a.

“The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.

Lemtrada is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy) and is only accessible to certified prescribers, healthcare facilities and specialty pharmacies. The program has been developed to properly educate healthcare providers and patients on the serious risks associated with the therapy and suitable monitoring measures required to support the detection of these risks for 48 months after the last infusion.

“The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States,” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option.”

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