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FDA approves drug for relapsing forms of MS

The FDA recently approved Mayzent, a next generation, selective sphingosine 1-phosphate receptor modulator, for the treatment of adults with relapsing types of multiple sclerosis such as active secondary progressive disease, relapse remitting disease and clinically isolated syndrome, according to agency and company press releases.

“One of the most important aims of MS treatment is delaying disability progression and preserving cognition,” Paul Hudson, CEO, Novartis Pharmaceuticals, said in the company release.

“With Mayzent, [secondary progressive multiple sclerosis] patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity,” he added.

Patients will not need a first dose observation with Mayzent (siponimod, Novartis) unless they have certain pre-existing cardiac conditions, according to the company.

Novartis also said the drug’s approval was based on a phase 3 randomized, double-blind, placebo-controlled study where patients with secondary progressive multiple sclerosis saw reductions or delays in confirmed disability progressions and annualized relapse rates.

The company said siponimod also showed other “significant favorable outcomes” prevalent in patients with MS, including brain volume loss, cognition and MRI disease activity. The most common adverse events were headache, hypertension, and transaminase increase, and these occurred in 10% or more of patients.

  

The FDA recently approved Mayzent, a next generation, selective sphingosine 1-phosphate receptor modulator, for the treatment of adults with relapsing types of multiple sclerosis, according to agency and company press releases.

Source: Adobe

According to the FDA, siponimod must be dispensed along with a patient medication guide, may increase infection risk, cause macular edema, short-term decreases in heart rate and a decline in lung function. Due to the possible risk for fetal harm, women of childbearing age should use birth control during and for 10 days after using siponimod. The agency added that health care professionals should monitor patients for posterior reversible encephalopathy syndrome and those patients treated with immunosuppressive/immune-modulating therapies since there may be unintended additive immunosuppression with siponimod.

Siponimod is expected to be available in early April. – by Janel Miller

Disclosure: Hudson works for Novartis Pharmaceuticals.