Bristol Myers flags another PhIII success for one of their top blockbuster prospects, clearing a path to the FDA
Researchers for Bristol Myers Squibb say they have cleared the second big Phase III hurdle for their blockbuster psoriasis contender deucravacitinib, clearing the path to an FDA filing with more data to prove the oral drug’s superiority to Otezla.
Once again, there are no hard data to report, as the Bristol Myers team is holding the numbers for a scientific conference, but company CMO Samit Hirawat says that they once again nailed down statistically significant and clinically meaningful data to demonstrate their drug came through on two key secondaries, with 6 mg once daily proving superior to Otezla (apremilast) in the proportion of patients reaching PASI 75 and sPGA 0/1 at Week 16. The co-primary endpoints of superiority over a placebo — a necessary though not particularly tough objective — were also met.
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