Healthcare company Merck reported on Friday the receipt of Health Canada's approval for MAVENCLAD (Cladribine Tablets) as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS).

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. The relapsing forms of MS are the most common.

The company said MAVENCLAD is recommended 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 or who are unable to tolerate, one or more therapies for multiple sclerosis. It is the first and only oral short-course treatment to provide efficacy across key measures, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity.

According to the company, 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.

This clinical development programme of MAVENCLAD (cladribine tablets) includes the CLARITY (cladribine tablets Treating MS Orally) study, the CLARITY extension study, the ORACLE MS (Oral Cladribine in Early MS) study as well as the ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study, stated the company.

With expected launch in Canada in early January, 2018, the company plans additional filings for regulatory approval in other countries, including the US. The Health Canada Notice of Compliance follows the European Commission (EC) marketing authorization received in August 2017.