Posted by Michael Wonder on 05 Dec 2017
EMD Serono receives Health Canada Notice of Compliance for Mavenclad (cladribine tablets) for patients living with relapsing-remitting multiple sclerosis
4 December 2017 - EMD Serono Canada announced today that Health Canada has approved Mavenclad (cladribine tablets) as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations and delay the progression of disability.
Mavenclad is generally recommended in multiple sclerosis patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis.
The Health Canada approval of Mavenclad is based on the safety and efficacy data from the pivotal phase III CLARITY study. The clinical development program includes more than 10,000 patient years of data with over 2,700 patients included in the clinical trial programs4 and up to 10 years of observation in some patients.
