Janssen's Ponvory approved after beating competitor in trial

The US Food and Drug Administration (FDA) has approved Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

This approval is based, in part, on a two-year, head-to-head Phase III trial in which Ponvory 20mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide 14mg in patients with relapsing MS.

Teriflunomide, sold by Sanofi (Euronext: SAN) under the name Aubagio, has been approved in the USA since 2012 and in Europe from the following year.