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Janssen’s Ponesimod outclasses Sanofi’s Aubagio in relapsing MS

Published on 13/09/19 at 08:44am

Johnson & Johnson subsidiary Janssen have announced results from its Phase 3 OPTIMUM trial showing superior efficacy to Sanofi’s Aubagio (teriflunomide) with its investigational drug ponesimod in adults with relapsing multiple sclerosis (MS).

In the two year head-to-head trial the S1P1 receptor modulator ponesimod demonstrated superiority on primary endpoints and most secondary endpoints.

The data was presented by Professor Ludwig Kappos, Chair of the Department of Neurology at University Hospital of Basel, Switzerland, who commented: “These data, in conjunction with the observed safety profile, underline the potential of ponesimod as a new treatment option for MS.”

Ponesimod is a drug Janssen added to its pipeline with its $30 billion buyout of Actelion in 2017 and is one of the several potentially lucrative drugs competing in the MS market.

Results from the study itself showed that treatment with ponesimod 14mg cut relapses by 30.5% up to week 108 of the study compared with Aubagio.

Janssen also underlined a new outcome scale measuring the impact of fatigue symptoms in MS demonstrating a statistically significant impact with ponesimod compared with Aubagio. Additionally there were a fewer number of active lesions detected by MRI scans.

Luc Truyen, Global Head of Development and External Affairs at Janssen, said: “Despite an ever-growing treatment landscape, unmet needs remain in helping patients with MS.

“We are thrilled… to present these pivotal findings as they mark the first head-to-head trial of two oral therapies for relapsing MS and demonstrate positive results for ponesimod compared to leading disease-modifying therapy.”

Other drugs being investigated include Celgene’s ozanimod which is under a delayed FDA review.

Data from Janssen’s OPTIMUM trial will be the basis for filings with the FDA and the European Medicines Agency; however there was no mention of when this will happen.

Nik Kiran


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