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

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 UnionAustraliaCanadaArgentina, 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.

Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that make up the lining of blood vessels — found in the umbilical cord of newborns.
Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that make up the lining of blood vessels — found in the umbilical cord of newborns.
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  1. Pik says:

    The magic acronym “RRMS”! I’m “PPMS”. My doctor wants me to try this,don’t think so. 10 pill yearly? Come on.I just wasted 2 yrs on Ocrevus every 6 months infusions, and I’m worse than when I started.

  2. Pik says:

    Also a ? If its 2yrs between doses,and it’s not working for someone,say after a year,can they move on to another DMT? New technology,improved DMT’s will become available.I need to wait until August to washout Ocrevus& start Mayzent. 2 years,too long a time.

  3. Cherie Watkins says:

    This is wonderful to hear. Another oral medication is wonderful. I am taking Tecfidera now and I would like to try Mavenclad.

  4. Poonam Sharma says:

    It is really a great news for me.Is it available in India or not? If not how we get this medicine? Please i want to know all about it.

    • Joana Carvalho says:

      Hi Poonam. Unfortunately I don’t believe it has been approved in India yet. At least I did not find any report saying so. I would recommend that you discuss your options with your doctor.

  5. Cynthia King says:

    I go see my neurologist this week. I have ‘active’ SPMS. My care plan is throw everything at the wall and see if it works. I loved Tysabri, but after two years and JC+ had to stop. Started Ocrevus in 2017, but I don’t think it’s working. I am curious what they will say about this.

  6. Caroline Coursey says:

    I don’t understand why it is only approved for 10 days per year when the Merck release said it takes 20 days to produce the 2 years free of relapse statistic. Did I miss something?

    • Joana Carvalho says:

      Hi Caroline. I am afraid I don’t understand your question. The treatment is based on a short treatment course of 10 days per year; if taken during two years that is a total of 20 days of treatment, and such treatment regimen (according to the FDA and Merck) “provides two years of proven efficacy”.

  7. Joey says:

    This sounds promising. Does anyone know the cost and if there are any assistance programs. I have SPMS and on a Medicare Advantage insurance plan.

  8. Karen says:

    Hi. I was diagnosed with active SPMS in December. I have been waiting since then to see an MS doctor. I finally have an appointment the 30th of this month. I am 64 years old. I was diagnosed with GBS in 1967. We think now it was MS all along. I had another flare-up with my hands in 1981 and since then the disease has been dormant until now. I have numbness in my hands and feet now. This medication looks like something that might help me. I will ask the doctor when I meet him!

  9. DJ Hartt says:

    Stopping RELAPSES do not equal stopping PROGRESSION.

    Mavenclad/cladribine, Ocrevus/ocrezulimab and Mayzent/siponimod have no effect on progression of the disease in NON-ACTIVE SPMS OR NON-ACTIVE PPMS above placebo as wisely pointed out by the FDA. The majority of progressive patients are non-active.

    Pharma (along with their paid neurologists) are once again providing false hopes with immunosuppressant medications while cashing in record profits with very little benefit for the progressive patient.

    At best, they may very slightly delay a progressive MS patient’s decline but to the same miserable endpoint. There is no current drug available which will actually improve the clinical situation of a progressive MS patient.

    When is this madness going to end with immunosuppressive drugs for progressive disease? Where are the neuroprotective products, remyelination and neurorestoration products that will actually improve clinical outcomes, not just slightly delay progression?

    • DJ Hartt says:

      This advertisement by Merck has now been up since April 1, 2019. How much does this website get paid by each individual Pharma company especially to stay up for a month. I think this website needs to start being transparent regarding conflicts of interest.

      • JonwMS says:

        I totally agree. I began to notice the obvious bias when Ocrevus first received FDA approval for treatment of SPMS in the US. Biogen’s Ocrevus, and it’s $3 billion in annual sales, is one example of the latest “progressive therapy” approvals providing meager therapeutic results and false hopes to patients in desperate need of affordable and effective treatment. Now that there are SO many therapies approved for treatment, one has to wonder why the cost has increased 20 fold since my diagnoses 15 years ago.

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