Sotyktu™▼ (deucravacitinib) granted Marketing Authorisation in Great Britain for the Treatment of Moderate to Severe Plaque Psoriasis in Adults

Sotyktu™▼ (deucravacitinib) granted Marketing Authorisation in Great Britain for the Treatment of Moderate to Severe Plaque Psoriasis in Adults

Deucravacitinib is a first-in-class TYK2 inhibitor and an oral, once-daily medication for adults affected by moderate to severe plaque psoriasis who are candidates for systemic therapy[i]

An estimated 1.8 million people in the UK are affected by psoriasis, with some patients reporting a significant impact on mental health[ii]^,[iii]

(Uxbridge, Middlesex, 15 May 2023) – Bristol Myers Squibb (BMS) today announced that Sotyktu (deucravacitinib) was granted Marketing Authorisation (MA) in Great Britain (GB) by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.1 The MA was based on pivotal data from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated deucravacitinib’s superior efficacy and ability to improve skin condition and symptoms compared to a placebo (primary endpoint) and apremilast (secondary endpoint) in adult patients with moderate to severe plaque psoriasis.[iv]^,[v]

Professor Richard Warren, The University of Manchester and Northern Care Alliance commented: “Despite affecting a significant percentage of the population and for many, having a serious impact on their physical and mental health, patients with chronic conditions such as psoriasis have few effective oral options to manage their condition. Today’s announcement will potentially offer eligible patients with a new treatment option to help manage the significant symptoms associated with their condition.”

Psoriasis is a life-long inflammatory condition that typically affects the skin, nails and joints. It can be a highly visible disease³ that has numerous consequences for patients, both physically and psychologically.2 Comorbidities of this condition include psoriatic arthritis, cardiovascular disease, metabolic syndrome, diabetes, inflammatory bowel disease and depression.3

It is estimated that up to 1.8 million people in the UK are affected by psoriasis, with 90% of people affected by plaque psoriasis, the most common form of the condition.2^,[vi] Despite the availability of effective systemic therapies, many patients with moderate to severe plaque psoriasis still face challenges in accessing appropriate care – including being undertreated or even untreated.[vii] Some patients also feel under-informed about their care and dissatisfied with the treatment options available to them.[viii]

Scientists, Engineers, Logistical Specialists and the Quality Team at the BMS site in Moreton, on the Wirral Peninsula near Liverpool, played a significant role in the CMC (Chemistry, Manufacturing and Controls) development of deucravacitinib.

Deucravacitinib is a selective allosteric tyrosine kinase 2 (TYK2) inhibitor and is taken as a once-daily, oral tablet.1 Pivotal data for deucravacitinib comes from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which compared the efficacy and safety of deucravacitinib compared to placebo (based on primary endpoints) and apremilast (based on secondary endpoints) in patients with moderate to severe plaque psoriasis.4^,5 In the POETYK PSO-1 trial, deucravacitinib demonstrated superiority compared to the placebo and apremilast; at 16 weeks it achieved significantly higher response rates for PASI 75 (58.4% (n = 194/332) versus 12.7% (n = 21/166) versus 35.1% (n = 59/168)) and sPGA 0/1 (53.6% (n = 178/332) versus 7.2% (n = 12/166) versus 32.1% (n = 54/168)).4 Efficacy outcomes in the POETYK PSO-2 trial were consistent with these results.5

The most commonly reported adverse reaction is upper respiratory infections (18.9%), most frequently nasopharyngitis.¹

– ENDS

Notes to editors

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a selective allosteric tyrosine kinase 2 (TYK2) inhibitor with a novel mechanism of action. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby mediating signalling of interleukin (IL)-23 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions.4^,5

Deucravacitinib is being studied in multiple immune-mediated diseases.4

About access to Deucravacitinib

Deucravacitinib is now licensed for use across the UK. This authorisation from the MHRA grants a licence in Great Britain while under the Northern Ireland Protocol, the MA granted by the European Commission (EC) in March 2023 authorises use in Northern Ireland. The EC decision also applies to the Republic of Ireland.

Deucravacitinib is in the process of being appraised by the National Institute for Health and Care Excellence (NICE) for routine NHS access in England and Wales. A separate submission has been made to the Scottish Medicines Consortium (SMC) and a separate submission will be made to the National Centre for Pharmacoeconomics (NCPE) in the Republic of Ireland.

Bristol Myers Squibb is committed to ensuring eligible patients can access this treatment as quickly as possible via UK health services and will continue to work in collaboration with all relevant authorities to help achieve this.

About POETYK PSO-1 and POETYK PSO-2

Pivotal data for deucravacitinib comes from the Phase 3, multi-centre, randomised, double-blind POETYK PSO-1 and POETYK PSO-2 clinical trials, which compared the efficacy and safety of deucravacitinib versus placebo and apremilast in patients with moderate to severe plaque psoriasis. The co-primary endpoints of both trials were measured by the proportion of patients achieving at least a 75% reduction in the Psoriasis Area and Severity Index (PASI) (PASI 75) and a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) (sPGA 0/1) at week 16 versus placebo.4^,5

In the POETYK PSO-1 trial, deucravacitinib demonstrated superiority compared to the placebo and apremilast; at 16 weeks it achieved significantly higher response rates for PASI 75 (58.4% (n = 194/332) versus 12.7% (n = 21/166) versus 35.1% (n = 59/168)) and sPGA 0/1 (53.6% (n = 178/332) versus 7.2% (n = 12/166) versus 32.1% (n = 54/168)).4 Efficacy outcomes in the POETYK PSO-2 trial were consistent with these results, with deucravacitinib achieving higher response rates for PASI 75 (53.0% (n = 271/511) versus 9.4% (n = 24/255) versus 39.8% (n = 101/254)) and sPGA 0/1 (49.5% (n = 253/511) versus 8.6% (n = 22/255) versus 33.9% (86/254)).5

Adverse event rates with deucravacitinib were similar to those with placebo and apremilast. The most frequent adverse events with deucravacitinib are upper respiratory infections (18.9%), most frequently nasopharyngitis.1

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and multiple sclerosis. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.

References:

[i] Sotyktu Summary of Product Characteristics.

[ii] About Psoriasis. (n.d.). Psoriasis Association. Available at https://www.psoriasis-association.org.uk/about-psoriasis. Last Accessed: May 2023.

[iii] Michalek, I. M., Loring, B. & John, S. M. Global report on psoriasis. (2016). Geneva, Switzerland: World Health Organization. Last Accessed: May 2023.

[iv] Armstrong, A. 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, J Am Acad Dermatol January 2023, Volume 88, Number 1, Pages 29-39. Last Accessed: May 2023.

[v] Strober, B. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program for Evaluation of TYK2 inhibitor psoriasis second trial, J Am Acad Dermatol, January 2023, Volume 88, Number 1, Pages 40-51. Last Accessed: May 2023.

[vi] Psoriasis: assessment and management. National Institute for Health and Care Excellence. Available at https://www.nice.org.uk/guidance/cg153/chapter/introduction. Last Accessed: May 2023.

[vii] Armstrong A., et al. Under-treatment of patients with moderate to severe psoriasis in the United States: analysis of medication usage with health plan data. Dermatol Ther (Heidelb). 2017 Mar; 7(1): 97–109. Last Accessed: May 2023.

[viii] Nash, A.S. et al. (2014) “Psoriasis Today: Experiences of healthcare and impact on quality of life in a major UK cohort,” Primary Health Care Research & Development, 2015 16(04), pp. 415–423. Last Accessed: May 2023.