Sanofi and its subsidiary Genzyme have been given marketing approval by the European Commission for Lemtrada (alemtuzumab), a treatment for multiple sclerosis.
Lemtrada is administered intravenously for adult patients suffering from relapsing remitting multiple sclerosis (RRMS).
The medication comes in 12mg doses and requires two annual treatments.
The initial treatment is an intravenous infusion administered on five consecutive days, and the second course is carried out on three consecutive days, 12 months later.
Genzyme CEO and president David Meeker said: "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.
"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."
Known side-effects of Lemtrada include infusion-related reactions, infections of the upper respiratory and urinary tracts, as well as lymphopenia and leukopenia, which involve having a low levels of white blood cells.
Heinrich-Heine-University Department of Neurology professor and director Hans-Peter Hartung said: "Multiple sclerosis necessitates a highly individualised treatment approach, and the increasing diversity of options is good news.
"The Lemtrada clinical trial data supports its potential to meaningfully address disability in active RRMS patients."
Lemtrada is currently being reviewed by other regulatory agencies.
The drug has been in active clinical development for more than ten years, and its clinical development programme comprised more than 1,700 patients.
Genzyme is waiting the FDA’s response to its supplemental Biologics License Application seeking approval for Lemtrada in the US, which it expects to receive in late-2013.
Image: Genzyme global headquarters in Cambridge, Maine, US. Photo: courtesy of Wikipedia.
