Rabiya Tuma, PhD
March 29, 2019
The US Food and Drug Administration today approved cladribine (Mavenclad; EMD Serono, Inc) tablets for treatment of adults with relapsing multiple sclerosis (MS) and active secondary progressive disease who have had insufficient response to other agents.
The approval comes nearly a decade after the agency initially rejected the drug because of safety concerns.
Now, data from a clinical trial that enrolled 1326 patients with relapsing forms of MS and at least one relapse in the prior 12 months show that the drug significantly decreases the number of relapses compared with placebo.
The agency cautions, however, that, because of continued safety concerns, the drug should be used only in patients who have not responded sufficiently to other treatments. It is also not recommended for MS patients with clinically isolated syndrome.
Further, the drug must be dispensed with a patient Medication Guide that describes associated risks. The cladribine label includes a Boxed Warning, noting an increased risk for malignancy and fetal harm. Patients of childbearing age should not take the drug unless they plan to use an effective form of contraception during treatment and for the 6 months following treatment.
Patients taking cladribine should undergo standard cancer screenings.
Also, physicians should monitor patients' blood cell counts before, during, and after treatment, as the drug has been associated with decreases in red and white cell counts as well as bone marrow suppression. Patients on cladribine may also be more prone to infections, and the drug has been associated with liver injury and with graft-versus-host disease following blood transfusions with nonirradiated blood.