Mavenclad approved for multiple sclerosis.
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved MAVENCLAD® (cladribine) tablets for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). MAVENCLAD is the first and only FDA-approved treatment for RRMS and active SPMS that provides two years of proven efficacy with a maximum of 20 days of oral treatment, during a two-year period.
Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). The MAVENCLAD label includes a boxed warning for potential risk of malignancy and risk of teratogenicity. The label appropriately defines the relevant associated contraindications.
“Multiple sclerosis is the leading cause of non-traumatic disability in young and middle-aged adults,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. “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.”
“As an investigator in the clinical trial program, I am pleased MAVENCLAD will now be available to patients in the U.S. 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, M.D., PhD, Director, Comprehensive Multiple Sclerosis Center at Jefferson University Hospitals, Philadelphia, PA. “Nearly one million individuals are afflicted with MS in the U.S. alone, according to a recent National MS Society sponsored study. MAVENCLAD is a welcome new oral treatment option for this heterogeneous and often unpredictable disease.”
Eighty-five percent of people living with MS are initially diagnosed with RRMS, characterized by attacks of new or increasing neurological symptoms. Most people with RRMS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function over time.1 SPMS can be further characterized at different points as either active (with relapses and/or evidence of new magnetic resonance imaging [MRI] activity) or not active.
“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 EMD Serono for their dedication to bring MAVENCLAD to the U.S. as the first short-course oral treatment option for the community.”
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