Bristol Myers makes the case for hopeful psoriasis as it waits in regulatory limbo – Endpoints News

0

Bristol Myers Squibb continues to tout more data for its experimental psoriasis drug which it hopes will shake up the market.

The pharma giant released two-year results from a long-term extension study of deucravacitinib, showing the drug remained effective after two years. The drug, which analysts say could generate 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 for up to two years of treatment, with response rates at week 60 of 77.7% and 58.7% for PASI 75, a measure of severity of the disease. The security profile also remained consistent and no new issues emerged.

Thursday’s results were consistent with Phase III psoriasis trials, dubbed POETYK PSO-1 and POETYK PSO-2 published in 2021. However, Bristol Myers may find it more difficult to expand to other indications, as the drug failed a Phase II hurdle in ulcer disease. colitis.

Jonathan Sadeh

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 began to build in February 2021 when BMS authorized another phase III study. Full results were not published until the following April, but Bristol Myers noted that the trial concluded with 58.7% and 53.6% of patients on deucravacitinib achieving a PASI 75 response in the studies. POETYK-PSO-1 and POETYK-PSO-2, respectively. Meanwhile, only 12.7% and 9.4% of placebo patients and 35.1% and 40.2% of Otezla patients achieved the same results.

However, despite the positivity, the drug will likely be scrutinized by the FDA and EMA. The FDA has already taken the hammer on a similar class of drugs in JAK inhibitors such as Pfizer’s Xeljanz, finding an increased risk of serious cardiac events. The FDA also changed the label for the JAK class after a review of AbbVie’s Rinvoq to limit use to certain patients who are not being treated effectively or are experiencing serious side effects with anti-TNFs.

US regulators have set a PDUFA date of September 10, 2022 for deucravacitinib.

Deucravacitinib would be the first FDA-approved TYK2 drug, and Bristol Myers hopes the differentiated pathway — and ostensibly more effective results — will help it in its rivalry with Amgen. Currently, Amgen’s Otezla is the first and only approved oral treatment for adult patients with plaque psoriasis of all severities, including mild, moderate and severe.

Share.

Comments are closed.