FDA Approves Second Drug For Active SPMS

Late last week, it was announced that Mavenclad (cladribine) received US FDA approval for the treatment of adults living with relapsing multiple sclerosis (MS). Importantly, this also includes people living with secondary progressive MS (SPMS) with active disease. This follows on from a similar announcement last week for the approval of Mayvent (siponimod). You can read our summary of that news here.

Mavenclad works by reducing the number of T and B lymphocytes circulating around the body. These T and B cells have been shown to be important in causing damage in multiple sclerosis, so reducing them is a useful strategy for treating the disease. One of the major advantages of this treatment is that it is an oral therapy that only requires a maximum of 20 days of treatment, but is effective for at least 2 years.

This approval is based largely on the result of positive results being generated in a Phase 3 clinical trial, known as the CLARITY study. The study included 1,326 people living with relapsing-remitting multiple sclerosis (RRMS) that had at least one relapse in the previous 12 months and an EDSS between 0 and 5.5. The results showed that:

• Treatment with Mavenclad caused a reduction in the number of relapses. As well as this, an increased number of people who received Mavenclad had no relapses within 2 years of the treatment compared to placebo (81% compared to 63%).
• Fewer participants in the group that received Mavenclad had progression of disability when compared to those in the placebo group
• Fewer new and total lesions, as seen by MRI, were observed in participants that received Mavenclad compared to placebo

It is important to mention that Mavenclad may lead to a number of side-effects that can cause varying levels of concern. For this reason, the FDA included in their approval the following statement:

“Because of its safety profile, 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”.

Further information about this can be found by reviewing the full FDA statement here.

It should also be noted that Mavenclad has previously received approval in many countries throughout the world. In Australia, the treatment is approved by the Therapeutic Goods Administration (TGA) for the treatment of RRMS. Late last year, this was also added to the Pharmaceutical Benefits Scheme (PBS). Currently, our understanding is that it is not approved for use by people with active SPMS in Australia.

Those who wish to can also read the formal announcement of this news by Merck here.