PARIS (dpa-AFX) - Genzyme, a Sanofi company (SNY, SNYNF.PK), Friday said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency, issued a positive opinion for approval of Lemtrada or alemtuzumab. The compound is intended for the treatment of adult patients with relapsing remitting multiple sclerosis or RRMS with active disease defined by clinical or imaging features.
Along with this, the CHMP also issued a positive opinion on new active substance designation or NAS for Aubagio or teriflunomide, an immunomodulator with anti-inflammatory properties. This comes after the earlier positive opinion of recommending the approval of Aubagio for the treatment of adult patients with relapsing remitting multiple sclerosis.
In the US, the FDA has accepted to review the supplemental Biologics License Application or sBLA file seeking approval of Lemtrada. FDA action on the application is expected later this year.
The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to Rebifin patients with relapsing-remitting multiple sclerosis who had active disease and were either new to treatment or who had relapsed while on prior therapy, as well as an ongoing extension study.
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