Public health agency the US Food and Drug Administration stated on Friday that it has approved Mavenclad (cladribine) tablets for treating relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communications between the brain and other parts of the body. MS is among the most common causes of neurological disability in young adults and occurs more frequently in women than in men.

This US FDA approval of Mavenclad was granted to EMD Serono Inc.

According to the agency, the 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 MS, due to its safety profile.

In conjunction, the efficacy of Mavenclad was shown in the company's clinical trial in 1,326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Mavenclad significantly decreased the number of relapses experienced by these patients compared to placebo as well as reduced the progression of disability compared to placebo. Mavenclad must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.