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Home Pfizer’s JAK Inhibitors Cibinqo (abrocitinib) and Xeljanz (tofacitinib) Receive Positive CHMP Opinions for Atopic Dermatitis and Ankylosing Spondylitis

Pfizer’s JAK Inhibitors Cibinqo (abrocitinib) and Xeljanz (tofacitinib) Receive Positive CHMP Opinions for Atopic Dermatitis and Ankylosing Spondylitis

Oct 20, 2021 14:57 CST Updated 14:57
Pfizer

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Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


Atopic Dermatitis (Image source: icresearch.net)

October 19, 2021 /BioonBIOON/ --Pfizer(Pfizer) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending approvalCibinqo (abrocitinib, 100 mg, 200 mg): This drug is a once-daily oral JAK1 inhibitor indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.. Cibinqo was developed by PfizerNext-Generation Oral JAK1 Inhibitor, already approved in the UK and Japan,For the treatment of moderate to severe atopic dermatitis (AD) in adolescent and adult patients aged ≥12 years.

Additionally, the CHMP also issued a positive opinion recommending approvalOral JAK inhibitor Xeljanz (tofacitinib)A new indication: for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

Xeljanz is an oral JAK inhibitor approved for four indications in the European Union, the highest number among all JAK inhibitors., including: (1) moderate to severe active typeRheumatic Arthritis(RA) adult patients; (2) adult patients with active psoriatic arthritis (PsA); (3) adult patients with moderately to severely active ulcerative colitis (UC); (3) patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile PsA.

Mechanism of Action of Tofacitinib: JAK Inhibition (Image source: PMID 24883332)

The CHMP opinion will now be submitted to the European Commission (EC) for review, which is expected to issue a final decision on the applications for abrocitinib and Xeljanz by the end of this year. If the EC grants a centralised marketing authorisation, it will be valid in all EU Member States, Iceland, Liechtenstein, and Norway.

Pfizer Global Product Development, Inflammation &ImmunologyDr. Michael Corbo, Chief Development Officer, stated: "The CHMP’s positive recommendation brings us closer to our goal of helping European patients with moderate-to-severe atopic dermatitis achieve symptom relief. We look forward to working with the European Commission and hope to make abrocitinib available to patients in Europe soon, and ultimately to more people worldwide living with this debilitating disease, many of whom currently have limited treatment options."

Dr. Diamant Thaci from the Comprehensive Center for Inflammation Medicine at the University of Luebeck, Germany, stated: "Atopic dermatitis is an inflammatory disease that affects the daily lives of millions. Compared with placebo, abrocitinib demonstrated significant efficacy, including relief of hallmark chronic pruritus, rapid improvement in skin clearance, disease extent, and severity, along with a favorable benefit-risk profile. If approved, abrocitinib has the potential to become an important new treatment option for patients with moderate-to-severe atopic dermatitis."

Molecular structure of abrocitinib (Image source: medchemexpress.cn)

Atopic dermatitis (AD) is a chronic skin disease characterized by skin inflammation and skin barrier dysfunction, presenting with erythema, pruritus, induration/papulation, and exudation/crusting. It is a severe, unpredictable, and often debilitating skin disease that significantly impacts the daily lives of patients and their families. AD is one of the most common chronic, relapsing childhood skin diseases, affecting up to 10% of adults and up to 20% of children worldwide. Many patients with moderate-to-severe disease experience inadequate disease control, requiring additional treatment options to alleviate the symptoms most important to them.

The active pharmaceutical ingredient of Cibinqo isAbrocitinib, an oral small molecule that selectively inhibits Janus kinase 1 (JAK1). Inhibition of JAK1 is believed to modulate multiple cytokines involved in the pathophysiology of atopic dermatitis (AD), including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

In September this year, Cibinqo was approved in the United Kingdom and Japan for the treatment of adolescent and adult patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy and have had an inadequate response to existing therapies. Currently, marketing applications for abrocitinib have been submitted for review in multiple countries and regions worldwide, including the United States, Australia, and the European Union. In the United States,FDAIn February 2018, abrocitinib was granted Breakthrough Therapy Designation (BTD) for the treatment of moderate-to-severe atopic dermatitis (AD).

In multipleClinical Trialabrocitinib demonstrated robust efficacy in alleviating the signs and symptoms of AD, including rapid relief of pruritus and clearance of skin lesions. Notably, in the head-to-head Phase 3 JADE DARE (B7451050) study, abrocitinib demonstrated statistical superiority over subcutaneous Dupixent (Chinese brand name: Dabituo; generic name: dupilumab) across all evaluated efficacy endpoints. (Bioon.com)