Health Canada has approved cladribine tablets (Mavenclad, Merck KGaA) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability.
“Cladribine is the first and only oral short-course treatment to provide efficacy across key measures of disease activity in patients with RRMS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity,” EMD Serono Canada, the biopharmaceutical business of Merck KGaA in the United States and Canada, notes in a news release.
Cladribine is prescribed for a maximum of up to 20 days over 2 years, the company said. Each treatment course consists of 2 treatment weeks where patients take one or two tablets daily for 4 or 5 days. Patients completing 2 years of treatment are followed by observation for another 2 years.
Cladribine works by predominantly and temporarily depleting B and T lymphocytes followed by lymphocyte reconstitution, without continuous immune suppression. Cladribine is generally recommended in patients with MS who have had an inadequate response to, or are unable to tolerate, one or more therapies for MS, according to the company.
Cladribine is a “unique and powerful new treatment for our patients that offers potent efficacy with only 20 days of oral treatment over two years,” Mark Freedman, MD, director of the Multiple Sclerosis Research Unit at the Ottawa Hospital, Ontario, Canada, said in the release.
Approval of cladribine in Canada was based on safety and efficacy data from a large clinical development program, including more than 10,000 patient-years of data with over 2700 patients and up to 10 years of observation in some patients.
The company expects cladribine to be available in Canada in early January 2018. The approval of cladribine in Canada follows European Commission marketing authorization in August 2017 for patients with highly active relapsing MS. The drug is not yet approved in the United States.
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