Genzyme, a Sanofi company, has obtained an approval from Health Canada for its Lemtrada (alemtuzumab) for the treatment of relapsing remitting multiple sclerosis (RRMS).
Health Canada has approved Lemtrada for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.
Approval for Lemtrada in Canada is based on data from the clinical development program, which compared treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease.
Lemtrada 12mg has been administered via intravenous infusion for five consecutive days, followed by a second course of treatment a year later, consisting of three consecutive days of infusions. The drug has been tested in approximately 1,500 patients.
Genzyme has recently received approval for Lemtrada in the EU and marketing applications for the drug are also under review in other countries, including the US and Mexico.
Genzyme president and CEO David Meeker noted the approvals of Lemtrada in Canada and the EU are further recognition of its potential as a transformative treatment option for patients living with active MS.
"Lemtrada is now approved in 30 countries, and we are very pleased that Canadian patients and physicians will have access to this important new treatment option," Meeker added.
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Alemtuzumab treatment results in the depletion of circulating T and B cells which are thought to be responsible for the damaging inflammatory process in multiple sclerosis.
The most common side effects observed with Lemtrada are infusion associated reactions and infections. Infusion associated reactions include headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills and flushing. Infections include nasopharyngitis, urinary tract and upper respiratory tract infections.
According to Genzyme, Lemtrada's use may cause autoimmune conditions that include thyroid disease, cytopenias, glomerulonephritis, and serious infections.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. In the US, Bayer HealthCare holds the right to co-promote alemtuzumab in multiple sclerosis.
