U.S. Food and Drug Administration Approves Sotyktu™ (deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis

Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years

Pivotal Phase 3 POETYK PSO clinical trials demonstrated superior efficacy of once-daily Sotyktu over placebo and twice-daily Otezla® (apremilast) in improving skin clearance

Sotyktu has a well-demonstrated safety and tolerability profile based on the POETYK PSO clinical trials

PRINCETON, NJ, USA I September 09, 2022 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved 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.1,2 Sotyktu is not recommended for use in combination with other potent immunosuppressants.

The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla® (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis.1 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. See below for more information.

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, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that affects approximately 7.5 million people in the U.S.3 Up to 90 percent 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 U.S., have cases that are considered moderate-to-severe.3

“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 Samit Hirawat, MD, 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.”

In the POETYK PSO trials, at Week 16, the most common adverse reactions (≥1 percent and higher than placebo) in patients on Sotyktu were upper respiratory infections (19.2 percent), blood creatine phosphokinase increase (2.7 percent), herpes simplex (2.0 percent), mouth ulcers (1.9 percent), folliculitis (1.7 percent) and acne (1.4 percent).1 In addition, 2.4 percent of patients on Sotyktu, 3.8 percent of patients on placebo, and 5.2 percent of patients on Otezla experienced adverse reactions leading to discontinuation.1,4

“Despite the availability of therapies, many people living with plaque psoriasis in the United States are untreated or undertreated,5,6” said Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation. “The FDA approval of a new oral treatment is exciting news for the psoriasis community. We welcome this new treatment option.”

Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program. Sotyktu is expected to be available to patients in the U.S. in September 2022.

About POETYK PSO-1 and POETYK PSO-2

The pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials evaluated the safety and efficacy of Sotyktu (6 mg once daily) compared to placebo and Otezla® (apremilast) (30 mg twice daily) in patients with moderate-to-severe plaque psoriasis. Both were multi-national, multi-center, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24. In total, 664 patients were enrolled in POETYK PSO-1 and 1,020 patients were enrolled in POETYK PSO-2. All participants had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy. Patients had a body surface area involvement of ≥10 percent, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician’s Global Assessment (sPGA) ≥3 (moderate or severe).

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index 75 and the percentage of patients who achieved static Physician's Global Assessment score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints included the percentage of patients who achieved PASI 75, PASI 90 and sPGA 0/1 compared to Otezla at Week 16 and Week 24.

POETYK PSO-1 (n=664) Results at Week 16 and Week 24
Endpoint* Time Sotyktu 6 mg
(n=330)
Placebo
(n=166)
P-value vs.
placebo
Otezla
30 mg
(n=168)
P-value vs.
Otezla
PASI 75*a Week 16 58%* 13%* P<0.0001 35% P<0.0001
Week 24 69% - - 38% P<0.0001
PASI 90b Week 16 36% 4% P<0.0001 20% P=0.0002
Week 24 42% - - 22% P<0.0001
sPGA 0/1*c Week 16 54%* 7%* P<0.0001 32% P<0.0001
Week 24 59% - - 31% P<0.0001
POETYK PSO-2 (n=1,020) Results at Week 16 and Week 24
Endpoint Time Sotyktu 6 mg
(n=511)
Placebo
(n=255)
P-value vs.
placebo
Otezla
30 mg
(n=254)
P-value vs.
Otezla
PASI 75*a Week 16* 53%* 9%* P<0.0001 40% P=0.0004
Week 24 58% - - 38% P<0.0001
PASI 90 b Week 16 27% 3% P<0.0001 18% P=0.0046
Week 24 32% - - 20% P=0.0002
sPGA 0/1*c Week 16* 50%* 9%* P<0.0001 34% P<0.0001
Week 24 49% - - 30% P<0.0001

*Co-primary endpoints for POETYK PSO-1 and POETYK PSO-2 were PASI 75 and sPGA 0/1 for Sotyktu vs. placebo at Week 16.
a. PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores.
b. PASI 90 is defined as at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores.
c. sPGA 0/1 is defined as a static Physician’s Global Assessment (sPGA) score of clear or almost clear.

Responses persisted through Week 52, as 82 percent (187/228) of patients who achieved PASI 75 with Sotyktu at Week 24 maintained their response at Week 52 in POETYK PSO-1. In POETYK PSO-2, 80 percent (119/148) of patients who continued on Sotyktu maintained PASI 75 response compared to 31 percent (47/150) of patients who were withdrawn from Sotyktu.

Through Week 16, infections occurred in 29 percent of patients treated with Sotyktu compared to 22 percent of those treated with placebo. The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of Sotyktu. Serious infections were reported in five patients receiving Sotyktu and two patients treated with placebo. Through Week 52, the most common serious infections reported were pneumonia and COVID-19. Malignancies (excluding non-melanoma skin cancer) were reported in three patients treated with Sotyktu.

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity.7 Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease,8 including approximately 7.5 million people in the U.S.3 Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe.3 Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis,6 which is characterized by distinct round or oval plaques typically covered by silvery-white scales.

About SotyktuTM

Sotyktu™ (deucravacitinib) is a selective, allosteric inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Sotyktu binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. Janus kinases function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.

Sotyktu is under regulatory review by the European Medical Association and other health authorities around the world for the treatment of moderate-to-severe plaque psoriasis and by Japan's Ministry of Health, Labour and Welfare for the treatment of adults with moderate-to-severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.

INDICATION

SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Limitations of Use:

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

SOTYKTU is available in 6 mg tablets.

Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.

About Bristol Myers Squibb’s Patient Access Support

Bristol Myers Squibb remains committed to providing assistance so that patients who need our medicines can access them and expedite time to therapy.

Bristol Myers Squibb offers various programs and resources to support access to therapies, including SOTYKTU, through our SOTYKTU 360 SUPPORT program. For additional information, call SOTYKTU 360 SUPPORT at 1-888-SOTYKTU (1-888-768-9588) 8 a.m. to 11 p.m. ET, Monday through Friday.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Otezla® (apremilast) is a registered trademark of Amgen Inc.

References

1 SOTYKTU Prescribing Information. SOTYKTU U.S. Product Information. September 2022. Princeton, N.J.: Bristol-Myers Squibb Company.
2 Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb) 2021;11(5):1763–1776. doi: 10.1007/s13555-021-00596-8.
3 Armstrong AW, Mehta MD, Schupp CW, et al. Psoriasis prevalence in adults in the United States. JAMA Dermatol. Published online June 30, 2021. doi:10.1001/jamadermatol.2021.2007.
4 Armstrong A, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial, Journal of the American Academy of Dermatology (2022), doi: https://doi.org/10.1016/j.jaad.2022.07.002.
5 Lebwohl M, Langley RG, Paul C, et al. Evolution of patient perceptions of psoriatic disease: results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey. Dermatol Ther (Heidelb). 2022;12(1):61-78. Doi: 10.1007/s13555-021-00635-4.
6 Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.
7 Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003–2011. PloS One. 2012;7(12):e52935.
8 World Health Organization. Global report on psoriasis. 2016. Accessed May 12, 2022. https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf.psoriasis?sequence=1

SOURCE: Bristol Myers Squibb

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