Bristol Myers builds the case for psoriasis hopeful as it waits in regulatory limbo
Bristol Myers Squibb continues to tout more data for its experimental psoriasis drug that it hopes will shake up the market.
The pharmaceutical giant posted two-year results from a long-term extension study of deucravacitinib, showing the drug remained effective after two years. The drug, which analysts predict can bring in billions in sales by 2026, is an oral TYK2 inhibitor for adult patients with moderate to severe plaque psoriasis.
According to the latest data, clinical efficacy was maintained through up to two years of treatment, with response rates at week 60 of 77.7% and 58.7% for PASI 75, a measure of the disease’s severity. The safety profile also remained consistent and no new issues popped up.
Thursday’s results were consistent with the Phase III psoriasis trials, dubbed POETYK PSO-1 and POETYK PSO-2 posted in 2021. Bristol Myers may find it more difficult to expand into other indications, however, as the drug failed a Phase II hurdle in ulcerative colitis.
Jonathan Sadeh, senior vice president of immunology and fibrosis development at Bristol Myers, said in a statement that the long-term follow-up results only add to the growing body of evidence for the drug.
The hype started ramping up in February 2021 when BMS cleared another Phase III study. Full results weren’t posted until the following April, but Bristol Myers noted that trial concluded by displaying 58.7% and 53.6% of patients on deucravacitinib achieving PASI 75 response in the POETYK-PSO-1 and POETYK-PSO-2 studies, respectively. Meanwhile, just 12.7% and 9.4% of placebo patients and 35.1% and 40.2% of patients on Otezla achieved the same results.
However, despite the positivity, the drug will likely go under a fine-tooth comb at the FDA and the EMA. The FDA has previously taken the hammer to a similar drug class in JAK inhibitors such as Pfizer’s Xeljanz, finding an increased risk of serious heart-related events. The FDA also changed the JAK class’ label after a review of AbbVie’s Rinvoq to limit use to certain patients who are not treated effectively or who experience severe side effects with the TNF blockers.
American regulators have set a Sept. 10, 2022 PDUFA date for deucravacitinib.
Deucravacitinib would be the first TYK2 drug approved by the FDA and Bristol Myers is hoping the differentiated pathway — and ostensibly more efficacious results — will help in its rivalry with Amgen. Currently, Amgen’s Otezla is the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate and severe.