Genzyme’s MS drug application accepted for review by US FDA

Hannah Blake

pharmaphorum

Sanofi’s Genzyme has announced that the FDA has accepted for review the company’s supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS).

The company also reported key highlights from the US launch of once-daily, oral AUBAGIO (teriflunomide).

“Genzyme is making a difference for people living with MS and realizing its vision of being leaders in MS. The initial uptake of AUBAGIO by U.S. prescribers shows the importance of a once-daily oral option in MS. In addition, the acceptance of the LEMTRADA file in the U.S. marks another important milestone in bringing this potentially transformative therapy to MS patients. We look forward to a series of product launches in 2013 in Europe and other major markets.”

Genzyme President and CEO, David Meeker, M.D.

Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2 2013.

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Related news:

Sanofi Filing for Lemtrada MS Drug Accepted for Review by FDA (Bloomberg)

Reference links:

Genzyme press release 

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