FDA approves new oral treatment for MS

FDA on Friday approved cladribine (Mavenclad—EMD Serono) tablets for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease. The drug is not recommended for MS patients with clinically isolated syndrome.

FDA on Friday approved cladribine (Mavenclad—EMD Serono) tablets for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease. The drug is not recommended for MS patients with clinically isolated syndrome. FDA notes that, "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." The drug's efficacy was demonstrated in a clinical trial involving more than 1,300 patients with relapsing forms of MS who had at least one relapse in the past year. Compared with placebo, cladribine significantly reduced the number of relapses by patients receiving the drug, and it reduced disability progression as well. According to FDA, cladribine must be dispensed with a patient Medication Guide describing important information about the drug's uses and risks. Cladribine includes a boxed warning about an increased risk of malignancy and fetal harm, and it should not be used in individuals with current malignancy. Others who should not use the drug include pregnant women and women and men of reproductive potential who do not plan to use effective contraception during treatment and for 6 months after the course of therapy because of the potential for fetal harm. Additional warnings include the risk of decreased lymphocyte counts, an increased risk of infections, and possible hematologic toxicity and bone marrow suppression. The most common adverse reactions reported by patients receiving cladribine in the clinical trial include upper respiratory tract infections, headache, and decreased lymphocyte counts.