First Short-Course Oral Therapy for Relapsing Forms of MS Granted FDA Approval


Cladribine (Mavenclad, EMD Serono) is the first oral multiple sclerosis drug to demonstrate 2 years of proven efficacy with a maximum of 20 days of treatment.

Officials with the FDA have approved cladribine (Mavenclad, EMD Serono), a new oral treatment for relapsing forms of multiple sclerosis (MS) in adults including relapsing-remitting disease and active secondary progressive disease, according to a press release.

With this approval, cladribine is the first oral MS treatment to provide 2 years of proven efficacy with a maximum of 20 days of treatment, according to manufacturer EMD Serono.

Cladiribine’s approval follows the FDA’s approval of siponimod just a few days prior. Siponimod was approved as an oral treatment specifically for patients with active secondary progressive MS, as well as other relapsing forms of disease.

The clinical trial program evaluating cladribine included 1976 patients who received therapy for a total of 9509 patient years, of which mean time on study including follow up was approximately 4.8 years and 24% of follow-up was for 8 years.

Overall, the data showed that:

  • Patients experienced a 58% relative reduction in the annualized relapse rate (ARR) with cladribine compared with placebo (0.14 versus 0.33, p<0.001).
  • Eighty-one percent of patients were free of relapses after 2 years of short-course oral treatment with cladribine, compared with 63% of patients who received placebo (p<0.05).
  • Patients treated with cladribine had a 33% reduction in risk of 3-month confirmed disability progression as measured by Expanded Disability Status Scale (EDSS) compared with placebo (p<0.05).
  • Patients taking cladribine experienced a lower median number of T1-weighted gadolinium-enhanced brain lesions and new or enlarging T2 brain lesions compared with patients with placebo (0 versus 0.33 and 0 versus 0.67, p<0.001).

“As an investigator in the clinical trial program, I am pleased Mavenclad will now be available to patients in the US,” Thomas Leist, MD, PhD, director, Comprehensive Multiple Sclerosis at Jefferson University Hospital, said in a statement. “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. Nearly 1 million individuals are afflicted with MS in the US alone, according to a recent National MS Society sponsored study. Mavenclad is a welcome new oral treatment option for this heterogenous and often unpredictable disease.”

The most commonly reported adverse effects in the phase 3 CLARITY trial were upper respiratory tract infection, headache, and lymphopenia.

Cladribine is generally recommended for patients who have had an inadequate response, or are unable to tolerate an alternate drug indicated for the treatment of MS, and is not recommended for use in patients with clinically isolated syndrome. Cladribine has a boxed warning for an increased risk of malignancy and fetal harm.


FDA Approves Mavenclad (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and Active Secondary Progressive Multiple Sclerosis [news release]. EMD Serono. Accessed April 1, 2019.

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