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FDA approves Siponimod (Mayzent) for multiple sclerosis

The US Food and Drug Administration (FDA) has approved siponimod ( Mayzent Novartis) for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease and active secondary progressive (SP) disease explained the agency.

"Multiple sclerosis can have a profound impact on a person's life," Dr. med. Billy Dunn, director of the Department of Neurological Products at the FDA's Center for Drug Assessment and Research, said in a statement. "We are committed to working with companies developing additional treatment options for patients with multiple sclerosis."

The approval was based on the results of the Phase 3 EXPAND trial in which 1

651 patients with SPMS and an extended disability status were randomized to a scale of 3.0 to 6.5 versus oral 2 mg siponimod once daily (1105 patients) or placebo (546 patients) for a period of up to 3 years or until the occurrence of a predetermined number of identified disability progression events.

At baseline the mean The time since the first symptom of multiple sclerosis was 16.8 years, and the mean time since switching to SPMS was 3.8 years. 64% of patients had no relapse in the last two years and 56% needed a walker.

The primary endpoint was the time to 3 months confirmed progression of disability. This occurred in 26% of the siponimod group and 32% of patients who received placebo (hazard ratio 0.79, 95% confidence interval [CI] 0.65-0.95, relative risk reduction 21%; P =. 013).

Severe adverse events were reported in 18% of patients receiving siponimod, compared to 15% in the placebo group. Lymphopenia, increased transaminase liver concentration, bradycardia and bradyarrhythmia at baseline, macular edema, hypertension, varicella-zoster reactivation, and convulsions were more common in siponimod than in placebo.

First dose titration with initial cardiac dose effects. Infection frequencies, malignancies and deaths did not differ between the groups.

In addition, secondary findings from the study suggest that the reduction in brain volume in patients who were treated with the drug compared to those who received a placebo (reduced mean percentage of brain volume) was less strong change around -0.50% vs. -0.65%, difference between the groups 0.15 percentage points [95% CI, 0.07 – 0.23 percentage points]; P = .0002.]

However, Siponimod was associated with no significant effect on patient walking speed in the timed 25-foot test.

Subgroup analyzes favored siponimod over placebo over the full length of the previous disease duration, disability status, and age, although the treatment effect was less pronounced with age, disability, disease duration, and diminishing signs of disease activity. [19659002] The drug must be dispensed with a drug guide for patients, which describes "important information about the use and risks of the drug". The treatment has been shown to increase the risk of infection, therefore, patients should be provided with a complete blood count before beginning treatment. It can lead to macular edema, "so patients should consult their doctor if they change their eyesight," the FDA adds.

It may result in transient bradycardia or impairment of lung function. Liver enzymes should be checked before starting the medicine. "Doctors and health professionals should closely monitor patients with severe hepatic dysfunction," the statement said. 19659003] Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug for potential risk According to the agency, "Health professionals should monitor patients for posterior reversible encephalopathy syndrome and monitor patients who have received treatment with immunosuppressive / immunomodulatory therapies, as there may be unintentional additive immunosuppression with siponimod.

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