The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS).
Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such as more than 80% MS specialists prescribing the drug, approximately one in five patients were new to Aubagio treatment and more than 50% of Aubagio patients were recently on Copaxone or Avonex.
Genzyme president and CEO David Meeker said the initial uptake by US prescribers marks the significance of Aubagio 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," Meeker added.
"We look forward to a series of product launches in 2013 in Europe and other major markets."
Comparison of Alemtuzumab and RebifEfficacy in Multiple Sclerosis I and II were randomized Phase III studies that compared Lemtrada to Rebif in treating na?ve patients with relapsing-remitting MS or patients who had relapsed while on prior therapy, respectively.
