Merck, a leading science and technology company, today announced that Health Canada has approved MAVENCLAD™ (Cladribine Tablets) as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. MAVENCLAD™ is generally recommended in multiple sclerosis (MS) patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis.[ii] MAVENCLAD™ 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.
“Mavenclad is a unique new treatment for our patients that offers potent efficacy with only 20 days of oral treatment over two years,” said Dr. Mark S. Freedman, Director, Multiple Sclerosis Research Unit at the Ottawa Hospital, Senior Scientist at The Ottawa Hospital Research Institute and investigator for the CLARITY study.
“Health Canada’s approval of Mavenclad represents a significant milestone,” said Rehan Verjee, EVP, Chief Marketing and Strategy Officer at the Biopharma business of Merck. “We are exceptionally proud of our long-standing partnership with the MS community in Canada and would like to thank the many Canadian patients and investigators who have supported the development of Mavenclad.”
MAVENCLAD™ is a selective immune reconstitution therapy[iii][iv] which simplifies treatment administration, by giving patients just two short annual courses of tablets with a maximum of 20 days of treatment over two years. MAVENCLAD™ works by selectively targeting B & T lymphocytes followed by a distinct pattern of lymphocyte reconstitution, without continuous suppression of the immune system.2
The Health Canada Notice of Compliance follows the European Commission (EC) marketing authorization received in August 2017. Product availability in Canada is expected in early January 2018. Merck plans additional filings for regulatory approval in other countries, including the United States.
MAVENCLAD (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis (RMS) and Canada for the treatment of relapsing-remitting multiple sclerosis (RRMS). MAVENCLAD is a short-course oral therapy that selectively targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for cladribine tablets for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.