FDA nod for Sotyktu in moderate-to-severe plaque psoriasis
The US Food and Drug Administration (FDA) late on Friday announced the approval Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Developed by US pharma major Bristol Myers Squibb (NYSE: BMY), Sotyktu is not recommended for use in combination with other potent immunosuppressants. Sales of $4 billion have been forecast in 2029 by BMS, which is also trialing deucravacitinib in psoriatic arthritis and Crohn’s disease.
The approval is based on results from the pivotal Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Amgen (Nasdaq: AMGN) drug Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks.
Sotyktu’s list price is around $75,000 a year, which is a premium to Otezla at about $52,000 a year. BMS has indicated that Sotyktu is expected to be available in the USA this month.
BMS acquired rights to the drug with its acquisition of Celgene in 2019 for $74 million, and opted to keep the dermatology and immunology drug deucravacitinib, as opposed to already-approved Otezla, which, because of competition issues, was sold on to Amgen for $13.4 billion.
The FDA accepted the filing in November last year, setting a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. The European Medicines Agency validated the BMS’ filing at the same time.
Potential to be new standard of care oral treatment
“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program,” said Dr April Armstrong, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California, adding: “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”
“The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments. This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis,” said Dr Samit Hirawat, chief medical officer, Bristol Myers Squibb. “We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases,” he opined.
Up to 90% of patients with psoriasis have plaque psoriasis, which is characterized by distinct, round or oval plaques typically covered by silvery white scales. Nearly one-quarter of people with psoriasis, or around two million in the USA, have cases that are considered moderate-to-severe.
12-09-2022
