The UAE MOHAP Approves the First and Only Therapy for the Treatment of Adult Generalized Pustular Psoriasis Flares

Boehringer Ingelheim, one of the world’s leading research-driven biopharmaceutical companies, has recently launched its treatment for (GPP) Flares in the United Arab Emirates (UAE), offering relief to patients with the rare skin condition. In addition to this treatment addressing a high unmet medical for patients’ physical symptoms, it also contributes to improving the overall quality of life of people living with GPP, marking an important advancement in the regional management of the condition.

Generalized Pustular Psoriasis (GPP) is a rare and severe form of psoriasis that affects the skin, causing painful, pus-filled blisters to erupt on the body. GPP patients tend to have sudden flares that can last for a few weeks and are quite unpredictable. ^{2, 5} The debilitating skin condition takes over multiple facets of a person’s life affecting employment, relationships, and overall wellbeing.  In addition to the chronic nature of GPP, patients are often subjected to stigmatization largely due to the baseless fear that the condition is contagious, and studies have reported that a higher proportion of patients with GPP had clinically reported anxiety and depression.⁶

Spesolimab, Boehringer Ingelheim’s treatment for GPP flares, was granted approval by the Ministry of Health and Prevention (MOHAP), UAE in July 2023. Additionally, the infusion therapy was granted conditional marketing authorization by the European Commission, based on evidence from the EFFISAYIL® 1 trial, which demonstrated that over half of the spesolimab-treated patients were free of pustules, one week after receiving a single dose.⁷ Spesolimab, is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.^8,9,10,11,12

Ousama Alhaj, General Manager and Head of Human Pharma at Boehringer Ingelheim, Near East and UAE, said, “Boehringer Ingelheim is proud to bring this much needed treatment to patients living with GPP. We recognize how devastating this rare skin disease can be for patients, their families and caregivers. GPP can be life-threatening and until today there have been no specific approved therapies for treating the devastating GPP flares in the UAE. As a research-driven company, our commitment lies in bridging medical gaps by advancing the science behind our rare disease therapies, paving the way for improved health outcomes and fulfilling our purpose of transforming lives today and for generations to come.”

Marjan Maghami, Medical Director at Boehringer Ingelheim, Near East and UAE, said, “The onset of a GPP flare may start with the skin turning red and feeling tender, followed by the formation of pustules. These flares are unpredictable and can have a widespread impact on daily activities. The approval of spesolimab brings much-needed relief to the patients living with this debilitating and visible skin condition. Following the prescribed treatment plan can help improve skin symptoms and other symptoms, such as fever, joint pain, and extreme tiredness. The goal of treatment is to make symptoms less severe, so that the patient can heal faster, resume their daily activities, and avoid complications that may require hospitalisation."

Dr. Muna Almurrawi, President of Emirates Dermatology Society, added: “Given that GPP flares can be fatal, often leading to emergencies and requiring urgent medical attention, innovative treatments such as Spesolimab mark a turning point in current GPP treatment landscape. Spesolimab acts by blocking the source of inflammation that may cause GPP flares thereby alleviating the symptoms resulting from the flare. Such advanced therapies hold promise in substantially enhancing quality of life for patients living with GPP.”

As a leading global biopharmaceutical company, Boehringer Ingelheim places patients at the heart of its mission and considers the specific therapeutic requirements of those grappling with the effects of debilitating rare skin conditions such as GPP. Additionally, as part of its patient support efforts, Boehringer Ingelheim launched a dedicated website, in English and Arabic, for GPP patients and their caregivers to improve their understanding of this rare skin condition. The website provides medically sound information about identifying symptoms and living with the condition in addition to sharing patient experiences.

–ENDS–

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com

References

1. Zheng M, Jullien D, Eyerich K. The Prevalence and Disease Characteristics of Generalized Pustular Psoriasis. Am J Clin Dermatol. 2022 Jan;23(Suppl 1):5-12. doi: 10.1007/s40257-021-00664-x. Epub 2022 Jan 21. PMID: 35061224; PMCID: PMC8801400.

2. https://www.psoriasis.org/generalized-pustular-psoriasis/

3. https://www.hcplive.com/view/unmet-needs-patients-generalized-pustular-psoriasis

4. https://patient.boehringer-ingelheim.com/us/products/spevigo/why-spevigo?s_kwcid=AL!6545!3!664842673114!e!!g!!spesolimab&cid=cpc:GoogleAds:3W_SPES_DTC_GADS_US_EN_BRAND_GENERIC_TRAFFIC_INFORMATION_g::Spesolimab_e_kwd-spesolimab&gclid=CjwKCAjwzN-vBhAkEiwAYiO7oEa4pHDELVYlJtKkIIj2-nH3WedHEcsTCoRB7xHwbQ-MS7izIspwbhoCNPEQAvD_BwE&gclsrc=aw.ds

5. Erin Hunter, A. E. (2023, February 1). Phase 2 data show Spesolimab may prevent flares in patients with rare generalized pustular psoriasis. Pharmacy Times. https://www.pharmacytimes.com/view/phase-2-data-show-spesolimab-may-prevent-flares-in-patients-with-rare-generalized-pustular-psoriasis

6. Grover S, Mehra A, Dogra S, Hazari N, Malhora N, Narang T, Sahoo S, Sharma S, Handa S, Avasthi A. Internalized Stigma and Psychiatric Morbidity among Patients with Psoriasis: A Study from North India. Indian Dermatol Online J. 2020 Sep 28;12(1):97-104. doi: 10.4103/idoj.IDOJ_345_20. PMID: 33768029; PMCID: PMC7982046.

7. https://www.boehringer-ingelheim.com/human-health/skin-diseases/gpp/european-commission-approves-spevigo-spesolimab-generalized

8. Bachelez H et al. Trial of Spesolimab for Generalized Pustular Psoriasis. NEJM. 2021;385:2431-40.

9. Crowley JJ, et al. A brief guide to pustular psoriasis for primary care providers, Postgrad Med. 2021;133(3):330-344.

10. Federal Drug Administration. New Drug Approvals for 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf. Accessed September 2022.

11. Furue K, et al. Highlighting Interleukin-36 Signalling in Plaque Psoriasis and Pustular Psoriasis. Acta Derm Venereol. 2018;98:5–13.

12. CHMP positive opinion. Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/spevigo. Accessed November 2022.