A new oral drug reduced relapses more than established drug teriflunomide in adults with multiple sclerosis in two late-stage clinical trials.
Remibrutinib also showed clinically meaningful results in slowing disability progression compared with teriflunomide.
Novartis said remibrutinib was well tolerated and showed no liver safety issues, consistent with previous studies.
The REMODEL-1 and REMODEL-2 trials compared remibrutinib with teriflunomide in adult patients.
Teriflunomide is sold by Sanofi under the brand name Aubagio.
Novartis plans to seek regulatory approvals for remibrutinib globally and present full trial results at a medical conference in Toronto.
Remibrutinib belongs to a class of medicines known as Bruton’s tyrosine kinase, or BTK, inhibitors. These drugs work by blocking inflammatory immune cells.
Earlier medicines in the same class have faced regulatory setbacks linked to liver toxicity.
Two patients died during the studies, although the deaths were not related to treatment.
Analysts said they would be looking for more detailed safety data.
In December, the US Food and Drug Administration declined to approve Sanofi’s BTK inhibitor tolebrutinib for slowing disability progression after it failed to show superiority to Aubagio in preventing relapses.
Roche’s fenebrutinib has also faced questions over its safety profile.
Remibrutinib is already approved for a chronic inflammatory skin condition that causes severe hives and is sold under the brand name Rhapsido.
Novartis is also testing the drug for another skin disease and food allergies.
Around 1.8m people worldwide are estimated to have multiple sclerosis, according to the latest World Health Organization data.
