Janssen’s MS pill outshines Sanofi’s Aubagio in phase 3 trial

Johnson & Johnson’s Janssen unit has announced phase 3 results showing that its ponesimod tablet outperformed Sanofi’s Aubagio pill in adults with relapsing multiple sclerosis.

Ponesimod is a drug J&J added to its pipeline through its $30 billion buyout of Actelion in 2017, and is one of several drugs closing in on this increasingly competitive market.

As reported by pharmaphorum last month, Novartis’ Arzerra, a repurposed cancer drug formerly owned by GlaxoSmithKline, outperformed Aubagio in a phase 3 trial last month.

Celgene’s ozanimod is also under review by the FDA, although the filing was delayed by more than a year because of administrative foul-up from the company.

Targeting a receptor known as S1P1, ponesimod works in a similar way to ozanimod and could be yet another option in MS on top of several other older drugs already approved, according to these latest data.

In the head-to-head phase 3 OPTIMUM study, ponesimod 14mg taken daily showed a statistically significant improvement in reduction of annualised relapse rate, the study’s primary endpoint.

Results presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference showed ponesimod cut relapses by 30.5% up to week 108 of the study compared with Aubagio (teriflunomide).

J&J also highlighted a new outcome scale measuring the impact of fatigue symptoms in MS, which showed a statistically significant impact with ponesimod compared with Aubagio.

Ponesimod also significantly reduced the number of active lesions as detected by MRI scans, but did not produce a statistically significant reduction in confirmed disability accumulation compared with teriflunomide.

The safety profile observed for ponesimod in the OPTIMUM study was consistent with previous studies of ponesimod and the known safety profile for other S1P receptor modulators, the company said.

The most commonly observed adverse events included nasopharyngitis, headache, upper respiratory tract infections and an increase in alanine amino transferase.

Data from OPTIMUM will be the basis for filings with the FDA and European Medicines Agency, but the company did not say when these are planned.

 

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.