Bristol Myers Squibb just released new two-year deucravacitinib data showing lasting efficacy for patients with moderate to severe plaque psoriasis. It means the drug could be going head-to-head with Amgen's Otezla as soon as September.
The company submitted its new drug application to the FDA based on earlier phase 3 data from the POETYK PSO trial and expects to hear back from the agency by Sept. 10. If given the nod, deucravacitinib would be the first allosteric tyrosine kinase 2 inhibitor approved for any disease.
It would also be BMS’ third first-in-class medicine launch this year, Samit Hirawat, M.D., chief medical officer at Bristol Myers Squibb, told Fierce Biotech. In March, the FDA approved the company’s cancer drug combo Opdualag for melanoma, followed by Camzyos in April for obstructive hypertrophic cardiomyopathy.
As BMS awaits word from the FDA, it presented fresh deucravacitinib data at this year’s European Academy of Dermatology Spring Symposium. The new long-term extension POETYK PSO-LTE trial data of over 1,200 patients globally showed that 6 mg of deucravacitinib once daily maintained clinical efficacy for up to two years of treatment.
The trial evaluated once-daily deucravacitinib for patients with moderate to severe plaque psoriasis as compared to placebo or Otezla—currently the only approved oral treatment for all severities of psoriasis. After 60 weeks, the response rate for reaching 75 on the Psoriasis Area and Severity Index was 77.7%, while 58.7% of patients were assessed as having clear or almost clear skin.
“We are very proud of bringing a new medicine for an area which still has high unmet medical need with the data set on deucravacitinib,” Hirawat said.
Over two years, an overall safety profile consistent with that seen in the shorter trials was observed. Adverse events continued to be predominantly mild or moderate, with the most common events still being nasal inflammation, upper respiratory tract infection and headache. No emerging safety signals were observed, BMS said.
The data underscore the significant potential deucravacitinib has as a new oral treatment for people living with plaque psoriasis requiring systemic therapy, Hirawat said. Most patients with moderate or severe psoriasis don’t receive treatment for a variety of reasons, including fear of injectables, availability or inadequate use, the CMO said. If approved, BMS will be able to chip away at the psoriasis market currently dominated by Otezla, which brought in sales of $451 million for the first quarter of 2022.
Deucravacitinib is a TYK2 inhibitor and does not inhibit JAK1, JAK2, or JAK3, meaning the therapy doesn’t have the same liabilities as JAK inhibitors, such as major adverse cardiovascular events or venous thromboembolic episodes, Hirawat said.
As well as in the U.S., deucravacitinib is currently under regulatory review in Europe and Japan. The drug is also being tested as a treatment for Crohn’s disease and discoid lupus erythematosus, along with ulcerative colitis, despite a previous failed trial in the latter indication.