Welcome back to the Clinical Corner. In this issue, I would like to provide you with an update on a few new medications that have been approved for the treatment of Multiple Sclerosis (MS).
In late March, the FDA approved 2 new medications: Mavenclad®(cladribine, Serono) and Mayzent®(siponimod, Novartis). What makes these new approvals unique is that they are the first medications approved for active secondary progressive Multiple Sclerosis, in addition to relapsing forms. This offers the availability of other options for patients who have either failed or progressed despite other therapies.
Mavenclad® was first reviewed by the FDA in 2011 but was rejected in part due to concerns about a higher rate of malignancy. Since that time, further studies have been performed that have shown the medication does not have a higher risk of cancer than other disease-modifying agents used in the treatment of MS. Mavenclad® offers a unique dosing regimen as patients will take two treatment courses of 4-5 days each for years 1 and 2, and then no additional treatment for years 3 and 4. The drug does remain active in the patient’s system for the 2 years they do not receive treatment. At this time, treatment with Mavenclad® beyond 4 years has not been studied.
Mayzent® is a sphingosine-1-phosphate (S1P) receptor modulator. This medication has a similar mechanism of action to a currently available MS treatment: Gilenya®. Unlike Gilenya, ® which requires first-dose monitoring for patients due to the potential for adverse effects, Mayzent® only requires first-dose observation for patients with specific cardiac conditions. Even though both medications have a similar mechanism of action, Mayzent® could have the advantage due to being approved for both relapsing and secondary progressive Multiple Sclerosis.
It will be interesting to see where these 2 new medications fit into the current management of Multiple Sclerosis. With nearly 1 million US adults suffering from this condition, continued development in new treatment options is important.
Thanks for stopping by and see you next month at Ron’s Clinical Corner.