Biotechnology company Genzyme has obtained Health Canada approval for its Lemtrada (alemtuzumab), indicated for treatment of relapsing remitting multiple sclerosis (RRMS).
Canadian approval for Lemtrada is for the management of adult patients with RRMS, with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.
Health Canada has approved Lemtrada based on study results from the clinical development program comparing the treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease.
According to the company, Lemtrada 12mg has a novel dosing and administration schedule of two annual treatment courses.
While the first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, the second course is delivered on three consecutive days, 12 months later.
The company has obtained approval for Lemtrada in the EU. Marketing applications for the drug are also under review in other countries, including the US and Mexico.
Genzyme president and CEO David Meeker said approvals of Lemtrada in Canada and the EU are further recognition of its potential as a 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 said.
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells that are thought to be responsible for 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.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialisation in multiple sclerosis. In the US, Bayer HealthCare holds the right to co-promote alemtuzumab in multiple sclerosis.
Image: Ribbon diagram of the Fab fragment of alemtuzumab, a monoclonal antibody, bound to a small synthetic antigen. Photo: courtesy of Fvasconcellos.