Relapsing-remitting multiple sclerosis disease (RRMS) and active secondary progressive disease treatment - FDA approves Mavenclad

Merck KGaA announced that the 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 for Clinically Isolated Syndrome (CIS). The Mavenclad label includes a boxed warning for potential risk of malignancy, and the risk of teratogenicity. The label appropriately defines the relevant associated contraindications.

In the clinical trial program, 1,976 patients received therapy for a total of 9,509 patient years, of which the mean time on study including follow-up was approximately 4.8 years and 24% of the follow-up was for eight years. Mavenclad demonstrated clinical efficacy across key measures of disease activity, such as annualized relapse rate, disability progression, and magnetic resonance imaging (MRI) activity: Patients experienced a 58% relative reduction in the annualized relapse rate with Mavenclad compared to placebo (0.14 vs 0.33, p<0.001). 81% of patients were free of relapses after two years of short-course oral treatment with Mavenclad, compared to 63% of patients who received placebo (p<0.05). Patients treated with Mavenclad had a 33% reduction in risk of 3-month confirmed disability progression as measured by Expanded Disability Status Scale (EDSS) compared to placebo (p<0.05). Patients taking Mavenclad experienced a lower median number of T1-weighted gadolinium-enhanced brain lesions and new or enlarging T2 brain lesions compared to patients with placebo (0 vs 0.33 and 0 vs 0.67) p<0.001).

The most common (> 20%) adverse reactions reported in the pivotal phase III study, CLARITY were upper respiratory tract infection, headache, and lymphopenia. Serious adverse reactions reported in the clinical program included malignancies (0.27 events per 100 patient-years) in MAVENCLAD treatment arms, compared to placebo patients (0.13 events per 100 patient-years), and herpes zoster infections (2.0% vs. 0.2%) and oral herpes (2.6% vs. 1.2%).