After fingolimod, more drugs in same class are close to approval for MS

Multiple sclerosis

By Michael Woodhead

5 Sep 2019

A new drug in the class of sphingosine 1-phosphate receptor modulators for MS has been shown to be effective  – and potentially safer than predecessors – in two trials published this week.

If it goes on to gain regulatory approval, ozanimod will follow fingolimod (Gilenya) and siponimod (Mayzent) as a treatment of secondary progressive MS, according to a commentary published in Lancet Neurology.

The journal published the results of the results of two phase 3 trials of ozanimod, in which the selective oral sphingosine 1-phosphate receptor modulator was compared to interferon beta-1a  in adults with relapsing–remitting multiple sclerosis and with recent inflammatory disease activity.

The SUNBEAM trial, which followed up patients for 12 months found that ozanimod was well tolerated and demonstrated a significantly lower relapse rate than interferon beta-1a.

Notably, given concerns about cardiac conduction adverse effects of fingolimod, there were no reports of  clinically significant bradycardia or second-degree or third-degree atrioventricular block.

The 24 month RADIANCE trial similarly showed that ozanimod was well tolerated and associated with a significantly lower rate of clinical relapses than intramuscular interferon beta-1a. And likewise, no cases of ozanimod-related symptomatic reduction in heart rate and no second-degree or third-degree cases of atrioventricular block were reported.

The commentary authors said the newer agent, like siponimid, was a more selective sphingosine 1-phosphate receptor modulator, with its main target of receptor subtype 1, which inhibits lymphocyte trafficking

Severe lymphopenia occurred in up to 4.2% of patients treated with the highest dose of ozanimod (1.0 mg)

In contrast, the first in class drug fingolimod, which has been in use for a decade, is a non-selective sphingosine 1-phosphate receptor modulator.

The results of the SUNBEAM  and RADIANCE ozanimod trials provide reassurance about the clinical efficacy and safety outcomes of sphingosine 1-phosphate bmodulators,” it concluded.

Meanwhile, siponimod  (Mayzent) is to be considered by the Pharmaceutical Benefits Advisory Committee (PBAC) meeting in November for possible subisidy on the PBS for people with secondary progressive MS.

MS Research Australia said submissions in support of the applications are invited by the PBAC from the MS community.

“MS Research Australia will be making a submission advocating for this treatment to be listed on the PBS, as we welcome affordable access to all treatment options that have been shown in clinical trials to provide safe and effective treatment for MS,” it said

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