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FDA approves new oral drug to treat multiple sclerosis in the US

The US Food and Drug Administration has approved siponimod (Mayzent) tablets to treat adults with relapsing forms of multiple sclerosis (MS), which will include clinically isolated syndrome, relapsing remitting and active secondary progressive MS (SPMS).

The efficacy of siponimod was shown in a clinical trial of 1,651 patients that compared siponimod to placebo in patients with SPMS who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrolment. The primary endpoint of the study was the time to three-month confirmed progression in disability. The fraction of patients with confirmed progression of disability was statistically significantly lower in the siponimod group than in the placebo group. Siponimod also decreased the number of relapses experienced by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.

Siponimod must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks. Siponimod may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated. The drug may cause macular edema (a build-up of fluid in the macula), so patients should contact their consultantif they experience a change in vision. Siponimod may cause short decreases in heart rate and may cause a decline in lung function. Liver enzymes should be checked before initiation of the drug and health care professionals should closely monitor patients with severe liver impairment. Health care professionals should monitor the patient's blood pressure during treatment. Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug due to the potential risk of foetal harm. Health care professionals should monitor patients for posterior reversible encephalopathy syndrome (characterised by headache, confusion, seizures and visual loss) and monitor patients that had treatment with immunosuppressive or immune-modulating therapies because there may be unintended additive immunosuppression with siponimod.

The most common adverse reactions reported by patients receiving siponimod in the clinical trials included headache, high blood pressure and liver function test increases.

For more information on MS drugs available in the UK, click here and download MS-UK’s free Disease Modifying Therapies Choices leaflet.

Source: MS-UK 29/03/19

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