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FDA approves its first drug for PPMS patients (31/03/17)

The US Food and Drug Administration (FDA) has approved Ocrevus, otherwise known as ocrelizumab, to treat adult patients with relapsing and primary progressive MS (PPMS). 

Ocrevus is the first drug the FDA has approved for people with PPMS. It is administered to patients in an intravenous infusion by their healthcare professional.

Billy Dunn, M.D., Director of the Division of Neurology Products at the FDA’s Centre for Drug Evaluation and Research said: “Multiple sclerosis can have a profound impact on a person’s life. This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif. In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.

In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving Ocrevus showed a longer time to the increase of disability compared to placebo.

However, Ocrevus is not without risk of causing a reaction. These reactions include, itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, tiredness, dizziness, headache and throat irritation to name a few.

Source: MS-UK (31/03/17)