Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression

Novartis announced initial results Wednesday from a Phase III study showing that its oral drug fingolimod was “significantly superior” to placebo in reducing both relapses and disability progression in patients with relapsing-remitting multiple sclerosis. Trevor Mundel, the company’s head of global development, said Novartis was on track to submit regulatory applications for the drug in the US and Europe in December.

The two-year FREEDOMS study enrolled 1272 patients with MS who received either placebo or one of two doses of fingolimod. Novartis said the trial met its primary and secondary endpoints for both doses of fingolimod, with no significant difference in efficacy between them. Data indicated that compared to placebo, the lower dose of the drug reduced the relapse rate in patients by 54 percent, while the higher dose reduced it by 60 percent. Additionally, fingolimod reduced the progression of disability by 30 percent for patients on the lower dose and by 32 percent for those on the higher dose compared to placebo over the study period.

The company noted that it will seek regulatory approval for the lower of the two drug doses used in the study, which was associated with “a lower incidence of adverse events,” and that future development of fingolimod will also focus on this dose.

Commenting on the results, Vontobel analyst Andrew Weiss said the data “confirm that [fingolimod] is superior to the current interferon-based gold standard of treatment," noting that the company’s decision to seek approval of the lower dose of the drug “is potentially good news as the safety profile is more benign.”

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