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Health Canada approves Merck’s mavenclad for relapsing-remitting multiple sclerosis

Darmstadt, Germany
Tuesday, December 5, 2017, 14:00 Hrs  [IST]

Merck, a leading science and technology company,  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. 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 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.

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.

 

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