UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Thursday, September 09, 2021 - 06:45am

-Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-

-This is the first marketing authorization globally for abrocitinib-

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over, who are candidates for systemic therapy. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. This is the first marketing authorization worldwide for this treatment.

“We welcome the MHRA’s authorization of abrocitinib to treat people with moderate to severe atopic dermatitis. This is an important development for people in Great Britain who have moderate to severe disease and need innovative treatment options,” said Angela Hwang, Group President, Pfizer Biopharmaceuticals Group. “Following marketing authorization, our priority now is to work with NICE and the Scottish Medicines Consortium (SMC) to ensure routine access so that patients with moderate to severe AD can benefit from this important treatment.”

Last year, abrocitinib received a Promising Innovative Medicine (PIM) designation from the MHRA. In January of this year, abrocitinib was granted a positive scientific opinion for an Early Access to Medicines Scheme (EAMS) from the MHRA for people with severe atopic dermatitis requiring treatment with systemic therapy and who have had inadequate response or have lost response to licensed systemic therapies, or who are ineligible or intolerant of licensed systemic therapies. This enabled healthcare professionals to prescribe the treatment prior to marketing authorization, based on clinical factors for patients with a clear unmet need.

Regulatory applications for abrocitinib have been submitted to countries around the world for review, including the United States, Australia, Japan, and the European Union.

About Atopic Dermatitis

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.i,ii Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.ii,iii

AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.iii,iv AD is the most common chronic inflammatory skin disease in the UK,v affecting approximately 20% of children and 10% of adults.vi

About CIBINQO®(abrocitinib)

CIBINQO (abrocitinib) is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).vii

SAFETY INFORMATION

A total of 3,128 patients were treated with CIBINQO in clinical studies in atopic dermatitis. There were 994 patients with at least 48 weeks of exposure. Five placebo‑controlled studies were integrated (703 patients on 100mg once daily, 684 patients on 200mg once daily and 438 patients on placebo) to evaluate the safety of CIBINQO in comparison to placebo for up to 16 weeks.

The most commonly reported adverse reactions occurring in ≥ 2% of patients treated with CIBINQO 200mg in placebo-controlled studies are: nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%).

For further safety information including warnings, precautions and adverse reactions, please refer to the Summary of Product Characteristics.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of 7 September, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate, abrocitinib, including an approval by the MHRA and their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for any potential indication for abrocitinib; whether and when the applications for abrocitinib pending with the U.S. Food and Drug Administration, European Medicines Agency, Australian Therapeutic Goods Administration, and Japan Pharmaceuticals and Medical Devices Agency may be approved and whether and when any such other applications that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether abrocitinib will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of abrocitinib; uncertainties regarding the commercial or other impact of the results of Janus kinase (JAK) inhibitor studies and data and actions by regulatory authorities based on analysis of such studies and data, which will depend, in part, on benefit-risk assessments and labeling determinations; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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i Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.

ii Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.

iii Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015:32(6):409-420.

iv Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16.

v Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nature Reviews Disease Primers. 2018;4(1):1.

vi National Eczema Society. What is Eczema? Available at: http://www.eczema.org/what-is-eczema. [Last accessed: August 2021]

vii Silverberg J I, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis. JAMA Dermatology. 2020;156(8): 863-873

PP-ABR-GLB-0162
September 2021

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Source: Pfizer Inc.