Bristol Myers Squibb has received U.S. regulatory approval for deucravacitinib, a first-in-class oral treatment for moderate-to-severe plaque psoriasis.
The drug, to be marketed under the brand name Sotyktu, is aimed at patients who are candidates for systemic therapy or phototherapy and is not recommended in combination with other potent immunosuppressants.
It represents the first approval by the U.S. Food and Drug Administration for a medicine based on tyrosine kinase 2 (TYK2), a member of the Janus kinase (JAK) family.
The agent is also under review by the European Medical Association and other regulators such as those in Japan for adults with moderate-to-severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
Deucravacitinib is an inhibitor of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs), though its precise action in plaque psoriasis is not known.
US approval was based on results from the phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which showed Sotyktu once daily was more effective than placebo and twice-daily use of the current treatment apremilast (Otezla) at 16 and 24 weeks in 1684 adults with moderate-to-severe plaque psoriasis.
“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 April Armstrong, POETYK PSO-1 trial investigator and dermatology professor at the University of Southern California.
BMS has also just announced results from the POETYK PSO long-term extension (LTE) trial, showing that continuous treatment with deucravacitinib maintained its efficacy in adults with moderate-to-severe plaque psoriasis.
The analysis, presented at this year’s European Academy of Dermatology and Venereology (EADV) Congress, followed POETYK PSO-1 trial participants who were treated for up to 2 years and who transitioned into the LTE trial.
The FDA approval and long-term trial results mark a change of fortunes for the drug, after the termination of a placebo-controlled trial examining its impact on kidney function in patients with lupus nephritis due to insufficient enrollment.
Last year, BMS also announced that the agent neither met its primary endpoint of clinical remission at 12 weeks, nor secondary efficacy endpoints for moderate-to-severe ulcerative colitis in the phase 2 LATTICE-UC study.
Following the FDA’s approval, BMS’s chief medical officer Samit Hirawat said: “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.
“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.”