J&J Nabs FDA Nod For Ponvory, Joining Novartis, Bristol Myers In Crowded MS Market

Another oral multiple sclerosis drug is here, challenging a slate of existing players that includes heavyweights Novartis, Bristol Myers Squibb, Sanofi and Biogen. Johnson & Johnson’s newly FDA-approved Ponvory, also known as ponesimod, is yet another S1P modulator to enter the U.S., joining Novartis’ aging blockbuster Gilenya and its follow-on Mayzent, as well as Bristol Myers’ newly approved Zeposia. And it’s “similar in price point to other treatments,” a company media aide said after the approval announcement. But the J&J drug has a set of phase 3 data those competitors don’t have—a head-to-head win against Sanofi’s blockbuster pill Aubagio. In a phase 3 study, a daily dose of Ponvory cut annual relapses by 30.5% over Aubagio, a widely used but older medicine. After two years, 71% of patients who got Ponvory had no confirmed relapses, compared with 61% for the Aubagio group. Plus, Ponvory showed it was better in terms of visible disease activity as shown on MRI. And Ponvory sported a numerical benefit in preventing disability from worsening. But without other head-to-head studies, it’ll be difficult to compare Ponvory’s efficacy with its direct rivals in the S1P class. Zeposia, for example, got its FDA go-ahead in relapsing MS based on clinical data comparing it with Biogen’s Avonex. But Ponvory does boast one advantage. RELATED: Janssen sends off NDA for new multiple sclerosis drug ponesimod Patients who received Ponvory can have their lymphocyte counts start to return to normal in one week after stopping treatment, which is shorter than its other in-class rivals, Allitia DiBernardo, M.D., global head of medical affairs of neurology at J&J’s Janssen pharma unit, said in an interview. S1P modulators work by blocking the excretion of lymphoid immune cells from entering the central nervous system to cause an inflammatory response. The fast reversibility is relevant in many situations, including vaccinations and family planning, because it can quickly give a patient a fully reconstituted, circulating immune population, DiBernardo explained. But then again, Ponvory’s rival list extends beyond the oral S1P class. Roche’s CD20-targeted injectable Ocrevus is quickly establishing itself as the new MS leader with 2020 sales of CHF 4.33 billion ($4.66 billion), thanks to a 24% year-over-year growth. And Novartis just launched its rival CD20 therapy Kesimpta. RELATED: Bristol Myers Squibb's Zeposia launches into crowded MS market The CD20 class is believed to be more potent than existing S1Ps at controlling MS. To make life difficult for Ponvory, Kesimpta has its own Aubagio head-to-head data—and it looks better than Ponvory’s.

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