Sanofi and its subsidiary Genzyme announced that the European Commission has granted marketing authorization for Lemtrada. This follows the Aug. 30 approval of Aubagio. The company intends to begin launching both products in the EU soon.
“The approvals of Lemtrada and Aubagio in the European Union represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to multiple sclerosis patients,” said Genzyme CEO and president, David Meeker. “This is particularly exciting as the EU approval is the first for Lemtrada globally. We look forward to making these unique therapies available to MS patients very soon.”
Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
The Lemtrada clinical development program included two pivotal randomized Phase 3 studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Serious autoimmune conditions can occur in patients receiving Lemtrada. A comprehensive risk management program will support early detection and management of these autoimmune events.
Aubagio 14 mg is a once-daily, oral therapy indicated for treatment of adult patients with RRMS. The EU approval was based on data from the Phase III TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trials. The EU approval of Aubagio includes new active substance designation.
“Multiple sclerosis necessitates a highly individualized treatment approach, and the increasing diversity of options is good news,” said Hans-Peter Hartung, professor and chairman of the Department of Neurology at Heinrich-Heine-University in Duesseldorf, Germany. “The Lemtrada clinical trial data support its potential to meaningfully address disability in active RRMS patients, while Aubagio’s efficacy, 2/4 safety and convenient dosing may provide an important alternative to injectable therapies. The approvals of Lemtrada and Aubagio represent a significant step forward in the way we think about treating this disease.”
Multiple sclerosis is estimated to affect more than 2.1 million people globally. There are approximately 630,000 people affected by MS in Europe.
“This is a hopeful time for people with MS,” said John Golding, president of the European Multiple Sclerosis Platform. “These approvals demonstrate the great progress being made towards introducing more differentiated treatment options that address important unmet needs.”
FDA action on Genzyme’s supplemental Biologics License Application seeking U.S. approval of Lemtrada (alemtuzumab) for the treatment of relapsing MS is expected in late 2013. Lemtrada is also under review by other regulatory agencies. Aubagio is approved to treat relapsing MS in the United States, Australia, Argentina, Chile and South Korea, and is under review by additional regulatory agencies.
Lemtrada has been in active clinical development for MS for more than 10 years. The clinical development program involved more than 1,700 patients.
Date: September 17, 2013