Mavenclad Approved to Treat Highly Active Relapsing MS Patients in Ireland

Adults in Ireland with highly active relapsing multiple sclerosis (MS) now can be treated with Mavenclad (cladribine tablets, 10 mg), the first short-course oral treatment approved for this disease.

The Irish Health Service Executive (HSE) has approved this new therapy and decided to reimburse patients for its associated costs, starting on September 2018. The decision follows the positive opinion of the Irish National Centre for Pharmacoeconomics (NCPE) announced in July 2018, which considered Mavenclad to be a cost-effective therapy.

“While there are many very useful treatments for MS, cladribine tablets [Mavenclad] provides additional choice which is both attractive and patient-friendly,” Orla Hardiman, professor at Trinity College Dublin, said in a press release.

“The swiftness of this approval is a testimony to the quality of the efficacy and safety data, and the well-defined cost effectiveness of this treatment,” Hardiman said.

Mavenclad is available in several countries worldwide, including Canada, Europe, Australia, Argentina, Israel, and the United Arab Emirates.

Merck KGaA, the therapy’s manufacturer, says it will continue to pursue the approval of additional marketing applications for this therapy in other countries.

In July 2018, the U.S. Food and Drug Administration accepted for review EMD Serono’s resubmitted new drug application (NDA) for cladribine tablets, seven years after it was first denied. EMD Serono is the biopharmaceutical business in the U.S. and Canada of Merck KGaA, Darmstadt, Germany.

Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps patients remain relapse-free for up to four years while supporting the “reset” of the immune system.

The Irish HSE decision was based on results from the Phase 3 CLARITY (NCT00213135) and CLARITY EXTENSION (NCT00641537) studies.

In these trials, the short-course treatment reduced the annualized relapse rate by up to 57 percent  compared to placebo in patients with highly active relapsing MS. This positive effect was accompanied by a reduced risk of six-month disability progression.

Mavenclad achieved this with only two short courses of treatment — with a maximum of 20 treatment days — in the first two years. The CLARITY EXTENSION trial showed that the benefits continued throughout the third and fourth years.

“Many people with MS are well and continue to live normal and productive lives but can be constantly reminded of their condition by the need to take regular medication. Cladribine tablets offers freedom in this regard as it is taken for a total of 4 weeks over 2 years, so people can get on with their lives without a constant reminder of their condition,” Hardiman said.

During the trials, the most clinically relevant adverse reactions reported were reduced levels of lymphocytes (white blood cells), and increased susceptibility to herpes infection. As such, patients’  lymphocyte levels must be assessed before and during the treatment.

“We are delighted that cladribine tablets are now available for patients with highly active relapsing MS in Ireland and are proud to have worked closely with both the HSE and NCPE to achieve this outcome,” said Roisin Molloy, head of Ireland at Merck. “This decision will not only see patients gain immediate access to this medicine, but it also stands to offer the Irish healthcare system the potential of considerable savings at a time of immense financial pressures.”

Mavenclad is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. It should not be used by patients who have a compromised immune system or women who are  pregnant.