FDA Accepts BMS Application for Psoriasis Therapy

The FDA has accepted Bristol Myers Squibb’s new drug application for deucravacitinib, a first-in-class therapy for the treatment of adults with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022. Additionally, the European Medicines Agency has validated the Marketing Authorization Application for deucravacitinib.

These applications were based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily deucravacitinib in patients with moderate-to-severe plaque psoriasis versus placebo and Amgen’s Otezla (apremilast).

Deucravacitinib demonstrated meaningful improvements in skin clearance, symptom burden and quality of life measures compared with placebo and with Otezla. Deucravacitinib was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities.

Jonathan Sadeh, M.D.

“There is a strong need for more effective and well-tolerated oral therapies for people living with moderate to severe plaque psoriasis, as many remain undertreated or even untreated,” Jonathan Sadeh, M.D., senior vice president of immunology and fibrosis development at Bristol Myers Squibb, said in a statement. “Findings from the pivotal POETYK-PSO trials demonstrate the potential of deucravacitinib to elevate the oral standard of care for individuals who are candidates for systemic therapy.”

Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor is designed to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferon.

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and about 7.5 million people in the United States.

Deucravacitinib is also being studied to treat patients with ulcerative colitis, but in October 2021, Bristol Myers Squibb released data from a phase 2 study in which the therapy did not meet the primary end point of clinical remission at week 12 or secondary end points, which included clinical response, endoscopic response and histological improvement.

The company said at the time that it will complete a full review of the data from LATTICE-UC and the potential of deucravacitinib in ulcerative colitis continues to be evaluated in IM011-127, a second phase 2 trial that also includes a higher dose.