FDA Approves EMD Serono’s Mavenclad as Treatment for RRMS and Active SPMS

The U.S. Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and active secondary progressive disease (SPMS).

Up to 85 percent of people with MS are initially diagnosed with relapsing forms of the disease, in which disease flare-ups (relapses) are followed by recovery periods (remissions). In some cases, these recovery periods are incomplete, and as a result, patients may still experience residual disabilities. Over time, most patients progress to a stage of the disease characterized by a gradual worsening of their symptoms that may be accompanied by recurrent relapses; this stage is known as active SPMS.

Mavenclad is a therapy developed and marketed by EMD Serono (known as Merck KGaA outside the U.S. and Canada) that works by reducing the number of immune cells in the patient’s bloodstream that are the cause of nerve degeneration in MS. Due to its safety profile, Mavenclad is normally recommended for patients who failed to respond or were unable to tolerate other treatments for MS.

“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “The approval of Mavenclad represents an additional option for patients who have tried another treatment without success.”

Mavenclad’s approval was supported by findings from a clinical trial program involving a total of 1,976 MS patients who were followed for a maximum of eight years.

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Pooled data from the studies showed that more than half of the patients (58%) treated with Mavenclad had a significant reduction in the annualized relapsed rate, compared with those on a placebo (0.14 vs 0.33).

In addition, results showed that more than three-quarters (81%) of the patients who received Mavenclad remained free of relapses over the following two years, compared with 63% of those on a placebo.

Mavenclad-treated patients were also less likely to develop new brain lesions or aggravate existing ones, and experience disability progression than placebo-treated patients.

In particular, a Phase 3 clinical trial (NCT00213135), called CLARITY, designed to assess the safety and efficacy of Mavenclad tablets among 1,326 patients with relapsing forms of MS, showed that the most common adverse events associated with treatment included upper respiratory tract infections, headaches, and low white blood cell counts (lymphopenia).

Serious adverse reactions included the occurrence of malignancies (0.27 events per 100 patient-years, compared with 0.13 events per 100 patient-years in the placebo group), and infections by herpes zoster (shingles; 2 vs. 0.2% in the placebo group) or oral herpes (2.6 vs. 1.2%).

All treatment risks associated with Mavenclad, including high risk of malignancy and fetal harm, are included in a boxed warning on the product label.

According to Merck, Mavenclad is now the first and only FDA-approved oral treatment for RRMS and active SPMS that provides two years of proven efficacy with a maximum of 20 days of oral treatment.

“We feel privileged to introduce Mavenclad into clinical practice in the United States. Mavenclad opens a new way to treat MS — a treatment that requires a maximum of 20 days of oral therapy to deliver two years of efficacy to a patient. This approval is a testimony to our long-standing commitment to people living with MS,” Belén Garijo, CEO healthcare and member of the executive board of Merck, said in a Merck release.

After being approved in more than 50 countries worldwide, including the European Union, Australia, Canada, Argentina, and the United Arab Emirates, Mavenclad will now be available to patients in the U.S.

“As an investigator in the clinical trial program, I am pleased Mavenclad will now be available to patients in the US. With short treatment courses with pills taken for no more than 10 days in a year and no injections or infusions, Mavenclad is an efficacious new treatment option for MS.” said Thomas Leist, MD, PhD, director of the Comprehensive Multiple Sclerosis Center at Jefferson University Hospitals in Philadelphia.

“The FDA approval of Mavenclad is excellent news for people living with RRMS and active SPMS. Mavenclad offers a new and effective option for some of those patients with an oral dosing schedule unlike any other treatment currently available,” said June Halper, CEO of the Consortium of MS Centers (CMSC).

“People living with MS should have the ability to work with their clinician to choose a treatment with a dosing schedule that supports their lifestyle. CMSC congratulates Merck for their dedication to bring Mavenclad to the U.S. as the first short-course oral treatment option for the community,” Halper concluded.

Mavenclad is not recommended for MS patients with clinically isolated syndrome (CIS). 

Merck has a patient support program in the U.S. — called MS LifeLines — that provides one-on-one assistance to patients prescribed a Merck MS therapy. The program will be expanded to include patients prescribed Mavenclad.