Genzyme said today it won marketing authorization from the European Union for its multiple sclerosis (MS) drug Lemtrada™ (alemtuzumab). The authorization represents the drug’s first regulatory approval, and the European Union’s second marketing nod for a Genzyme MS treatment in less than a month.
The Sanofi subsidiary said it will “soon” launch both Lemtrada and Aubagio® (teriflunomide) in the EU region. While Genzyme holds worldwide rights to Lemtrada, and has primary responsibility for its development and commercialization in MS, Bayer HealthCare retains an option to co-promote the drug in MS, and has told Genzyme of its intention to co-promote under this option. Bayer would receive contingent payments based on sales revenue, following regulatory approval and commercialization.
Lemtrada is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Genzyme is pursuing a supplemental Biologics License Application, seeking U.S. approval of Lemtrada for relapsing MS from the FDA, which is expected to take action later this year.
Lemtrada is indicated for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. At the 12 mg dose, Lemtrada requires just two annual treatment courses—the first one via intravenous infusion on five consecutive days; and the second on three consecutive days, 12 months later.
The European Union approved Lemtrada following two Phase III studies comparing the treatment 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). In addition, there is as an ongoing extension study.
In CARE-MS I, Genzyme said, 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, according to the company.
The trials capped more than 10 years of clinical development for Lemtrada, during which more than 1,700 patients were studied.
Lemtrada’s most common side effects are infusion-associated reactions, infections of the upper respiratory tract and urinary tract, lymphopenia, and leukopenia, while serious autoimmune conditions can also occur in patients receiving the drug. Genzyme said it will implement a comprehensive risk-management program that will support early detection and management of the autoimmune events.
“The Lemtrada clinical trial data support its potential to meaningfully address disability in active RRMS patients, while Aubagio’s efficacy, safety, and convenient dosing may provide an important alternative to injectable therapies,” Hans-Peter Hartung, M.D., Ph.D., professor and chairman of the department of neurology at Heinrich-Heine-University in Duesseldorf, Germany, said in a statement. “The approvals of Lemtrada and Aubagio represent a significant step forward in the way we think about treating this disease.”
Aubagio—a pyrimidine synthesis inhibitor that won EU authorization on Aug. 30—is a once-daily, oral therapy indicated at the 14 mg dose for treatment of adult patients with RRMS. EU approval of Aubagio includes a new active substance designation, and 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.