September9, 2022- Today, the U.S. Food and Drug Administration approved SOTYKTU (Deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
“Based on its ability to improve skin clarity shown in the POETYK PSO clinical trials, Sotyktu (Deucravacitinib) has the potential to set a new benchmark as an oral treatment for moderate-to-severe plaque psoriasis,” said Dr. April Armstrong, MD, MPH, clinical investigator for the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California. “Moderate-to-severe plaque psoriasis places a heavy burden on patients, and Sotyktu represents a promising first-choice systemic therapy.”
The approval was granted based on key findings from the Phase 3 POETYK PSO-1 and PSO-2 clinical trials, which included 1,684 adults with moderate-to-severe plaque psoriasis. These studies showed that once-daily Sotyktu was more effective than both a placebo and twice-daily Otezla® (Apremilast). This superior effectiveness was observed at weeks 16 and 24, with treatment benefits maintained through week 52.
Psoriasis is a common, long-term immune-related condition that affects around 7.5 million people in the U.S.3 About 90% of those diagnosed have plaque psoriasis, which typically appears as raised, round or oval patches covered in silvery-white scales. Approximately one in four patients—roughly two million Americans—have moderate-to-severe forms of the disease.
“The approval of Sotyktu (Deucravacitinib) marks an important milestone for people dealing with moderate-to-severe plaque psoriasis who haven’t found relief with topical or traditional therapies,” said Dr. Samit Hirawat, Chief Medical Officer at Bristol Myers Squibb. “It’s a significant accomplishment for our team, introducing a new mechanism of action, the first oral therapy approved in nearly a decade, and the only once-daily oral treatment available for this condition. We see Sotyktu as a breakthrough and are optimistic about its potential for treating other immune-mediated conditions as well.”
In the POETYK PSO clinical trials, the most commonly reported side effects at Week 16 in patients taking Sotyktu (occurring in at least 1% of patients and more frequently than with placebo) included upper respiratory tract infections (19.2%), increased blood creatine phosphokinase (2.7%), herpes simplex (2.0%), mouth ulcers (1.9%), folliculitis (1.7%), and acne (1.4%).1 Treatment discontinuation due to side effects occurred in 2.4% of Sotyktu users, compared to 3.8% in the placebo group and 5.2% in those taking Otezla.
“Even with available treatments, many individuals in the U.S. living with plaque psoriasis remain untreated or don’t receive adequate care,”5,6 noted Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation. “The FDA’s approval of a new oral therapy is welcome news for the psoriasis community, and we’re encouraged by this new option.”
Everest Pharmaceuticals launched the generic version of SOTYKTU under CRAVACIN brand name in 14 August 2023.
