Johnson & Johnson’s (J&J) pharma division Janssen has announced that the US Food and Drug Administration (FDA) has approved its multiple sclerosis (MS) treatment ponesimod, under the brand name Ponvory.
J&J submitted the drug to the FDA in March 2020, angling for an approval in patients with relapsing forms of MS.
The pharma giant acquired the S1P1 receptor modulator as part its $30bn takeover of Actelion, with the FDA approval based in part on the head-to-head phase 3 OPTIMUM study comparing Ponvory to Sanofi’s blockbuster MS therapy Aubagio (teriflunomide).
Data from that trial showed that treatment with Ponvory was associated with a statistically significant, 30.5% reduction in the annualised relapse rate (ARR) compared to Aubagio in patients with the relapsing form of MS.
Over the study period, 71% of Ponvory-treated patients had no confirmed relapses, compared to 61% in the Aubagio group.
J&J’s drug also outperformed Aubagio on fatigue scores, MRI assessments of the number of active lesions in the brain and the time to confirmed disability accumulation (CDA) – a measure of disease progression.
“Every person with multiple sclerosis is affected differently, given variability in both the underlying disease and emerging symptoms. Continued innovation in this space is critical, and we’re committed to meeting patients’ evolving healthcare needs,” said Mathai Mammen, global head, Janssen research & development, J&J.
“We are proud to offer Ponvory as a valuable new option for people with MS that may help them gain better control of their disease,” he added.
Now that Ponvory has received regulatory approval, it will enter an increasingly crowded market, with rivals including Novartis’ SLP receptor modulator franchise, which includes Gilenya (fingolimod) and follow-up Mayzent (siponimod).
In March 2020, the FDA also approved Bristol Myers Squibb’s (BMS) own S1P receptor modulator Zeposia (ozanimod) for the treatment of adults with relapsing forms of MS.
As well as the newer therapies, a range of blockbuster drugs are already available for MS, including Biogen’s Tecfidera (dimethyl glutamate) and new injectables like Roche’s Ocrevus (ocrelizumab).
There is also the looming threat of generic competition to Gilenya and Tecfidera, which could make it even more difficult for new drugs to make any significant return in the market.