Health Canada Approves Merck’s Mavenclad to Treat RRMS

Canadians with relapsing-remitting multiple sclerosis (RRMS) can now receive Merck’s Mavenclad (cladribine tablets), now that Health Canada has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression.

Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world’s highest MS rate.

This follows the drug’s approval by the European Commission in August, making Mavenclad Europe’s first approved highly efficient, oral short-course therapy for relapsing MS.

Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States.

“Health Canada’s approval of Mavenclad represents a significant milestone,” Rehan Verjee, chief marketing and strategy officer at Merck’s Biopharma division, said in a Dec. 4 press release. “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 was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotes long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system.

Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537) and ORACLE-MS (NCT00725985); the Phase 2 trial ONWARD study (NCT00436826); and the long-term study PREMIERE (NCT01013350). These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years.

“Mavenclad is a unique new treatment for our patients that offers potent efficacy with only 20 days of oral treatment over two years,” Mark S. Freedman, director of the Multiple Sclerosis Research Unit at Ottawa Hospital, and senior researcher of the CLARITY study at the Ottawa Hospital Research Institute.

Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse rates and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.