Genzyme's MS Treatment Lemtrada Wins Approval In Mexico
Sanofi company Genzyme announced this week that its multiple sclerosis (MS) drug Lemtrada (alemtuzumab) has been approved by Mexico’s national regulatory authority COFEPRIS. Lemtrada has been granted an orphan drug designation in the country.
Lemtrada (alemtuzumab) is a monoclonal antibody which targets CD52, a protein found on T and B cells. The treatment is used to retard or reverse accumulation of physical disability in patients with relapsing remitting forms of MS. The drug is also intended to reduce the frequency of clinical aggravation.
David Meeker, Genzyme President and Chief Executive Officer said, “The approvals in the European Union, Australia, Canada and now Mexico underscore Lemtrada’s potential to have a positive impact on the lives of MS patients. Genzyme remains committed to providing new hope for the MS community and plans this year to launch Lemtrada in more than 30 countries, and hopefully additional markets where the treatment is still under review.”
The drug is available in 12 mg dosing and recommended in an administration schedule of two annual treatment courses. The first treatment course is administrated via intravenous infusion on five consecutive days, while the second course is administered 12 months later on three consecutive days.
Lemtrada was evaluated by a broad clinical development program involving almost 1,500 patients and 5,400 patient-years of follow up. The program included two randomized Phase III studies which compared Lemtrada treatment with high-dose subcutaneous interferon beta-1a (Rebif). These were administered to patients with active RRMS disease and who were either new to treatment (CARE-MS I) or who experienced relapses while on prior therapy (CARE-MS II).
In both CARE-MS I and CARE-MS II, Lemtrada was observed to be more significantly effective at reducing annualized relapse rates.
Over 2.3 million people around the world have been positively diagnosed with MS, with an estimated 15,000 patients in Mexico alone.
Source:
http://news.genzyme.com/press-release/genzymes-lemtrada-approved-mexico-treatment-multiple-sclerosis