EMD Serono, a unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) had approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).

Mavenclad is the first and only treatment for RRMS and active SPMS approved by the FDA that provides two years of proven efficacy with a maximum of 20 days of oral treatment. The drug is typically recommended for patients who did not respond adequately to an alternate MS drug but is not recommended for patients with clinically isolated syndrome (CIS).

The FDA has also slapped the drug with a boxed warning for potential risk of malignancy and risk of teratogenicity.

“Multiple sclerosis is the leading cause of non-traumatic disability in young and middle-aged adults,” stated Belen Garijo, chief executive officer Healthcare and member of the Merck KGaA, Darmstadt, Germany executive board. “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.”

Of people living with MS, about 85 percent are initially diagnosed with RRMS. This is characterized by attacks of new or increasing neurological symptoms. Most individuals with RRMS eventually transition to a secondary progressive course where their neurologic function worsens over time. SPMS is further characterized at different periods as either active, with relapses and/or evidence of new magnetic resonance imaging (MRK) activity, or not active.

In the clinical program, 1,976 patients received therapy for a total of 9,509 patient years. The mean time on the study including follow-up was about 4.8 years and 24 percent of the follow-up was for eight years. The drug showed clinical efficacy across key measures of diseases activity, such as annualized relapse rate (ARR), disability progression and MRI activity.

The most common adverse reactions in the CLARITY Phase III trial were upper respiratory tract infection, headache and lymphopenia. Serious adverse reactions reported included malignancies and herpes zoster infections and oral herpes.

The company notes that after two treatment courses, additional courses should not be administered. Re-treatment with Mavenclad during years three and four can increase the risk of malignancy. On the other hand, safety and efficacy of restarting Mavenclad more than two years after completing two treatments haven’t been studied.

The drug was approved in the European Union in August 2017 and in over 50 countries.

“The FDA approval of Mavenclad is excellent news for people living with RRMS and active SPMS,” stated June Halper, chief executive officer of the Consortium of MS Centers (CMSC). “Mavenclad offers a new and effective option for some of those patients with an oral dosing schedule unlike any other treatment currently available. People living with MS should have the ability to work with their clinician to choose a treatment with a dosing schedule that supports their lifestyles. CMSC congratulates EMD Serono for their dedication to bring Mavenclad to the U.S. as the first short-course oral treatment option for the community.”