After a high-profile study turned up safety risks for Pfizer’s JAK inhibitor Xeljanz last year, the FDA put the entire class under a microscope—and it only recently went back to granting new approvals in that class. Bristol Myers Squibb, meanwhile, has a new candidate that the company’s chief medical officer says is safer than the other JAKs.
Speaking during the Fierce JPM Week virtual conference, Bristol’s CMO, Samit Hirawat, said the company’s deucravacitinib is a novel TYK2 inhibitor “with a very specific downstream effect of integrating IL-12, IL-23 and interferon and sparing other cytokines and sparing JAK 1, 2 and 3.”
While Bristol aims to highlight its med’s differences from drugs in the JAK class, TYK2 is known colloquially as JAK4 and is part of the Janus kinase family. That has some industry watchers worried that the FDA may take a tough stance on the candidate amid safety concerns for the larger drug class.
After an FDA submission last year, deucravacitinib is under review to treat moderate to severe plaque psoriasis. The agency’s decision deadline is set for Sept. 10, 2022.
So far in deucravacitinib’s studies, BMS doesn’t “see the hematologic impact that JAK inhibitors do show [and] we don’t see the dysfunction in the liver enzymes that is seen with JAK inhibitors,” Hirawat said during Fierce JPM Week.
Further, “we don’t see dyslipidemia that is shown by JAK inhibitors,” Hirawat added.
Since Xeljanz post-marketing study showed heightened risks of cardiovascular problems and cancer, the FDA has put the entire JAK inhibitor class in a protracted safety review. That process triggered missed approval deadlines for new drug candidates and delayed label expansions for existing meds.
More recently, the FDA started giving new blessings for JAK drugs—but under the condition that they’re used behind old-school TNF inhibitors such as Humira.
As for deucravacitinib, Hirawat said the Poetyk PSO-1 and Poetyk PSO-2 studies—plus trials in Japan and China—show that the med is a “first-in-class” medicine, apparently hoping to differentiate the drug from existing meds at the center of the FDA safety review.
These days, Amgen markets Otezla and is generating blockbuster sales from the psoriasis medicine. For its part, Bristol figures deucravacitinib can generate $4 billion at peak.
And deucravacitinib has some other new indications in the works. BMS is “looking forward to seeing the data imminently” for a phase 2 trial in systemic lupus erythematosus, Hirawat said. If that result is “supportive,” BMS will launch a phase 3 program, he said.
Meanwhile, the drug didn’t meet proof of concept criteria in inflammatory bowel disease last October, but Hirawat said the company is running two studies with higher doses and is “absolutely” committed in that disease. With those results, the company expects to have more information about potential indications to “pursue in the future,” Hirawat said.