The EU CHMP recommends the approval of Pfizer's 2 JAK inhibitors, Cibinqo (abxitinib) and Xeljanz (tofacitinib)!

EU CHMP recommends approval: Cibinqo treats atopic dermatitis, Xeljanz treats ankylosing spondylitis
.

Atopic dermatitis (picture source: icresearch.
net)

October 19, 2021/Bio Valley BIOON/ --Pfizer (Pfizer) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting that Cibinqo (abrocitinib, Abxitinib, 100mg, 200mg): This drug is a once-daily oral JAK1 inhibitor for the treatment of moderate to severe atopic dermatitis (AD) adult patients who are suitable for systemic treatment
.

Cibinqo is a new generation of oral JAK1 inhibitor developed by Pfizer.

In addition, CHMP also issued a positive review suggesting that the oral JAK inhibitor Xeljanz (tofacitinib, tofacitinib) be approved for a new indication: for the treatment of active ankylosing spondylitis (AS ) Adult patients
.

Xeljanz is an oral JAK inhibitor.
It has been approved for 4 indications in the European Union and is the largest of all JAK inhibitors, including: (1) Adult patients with moderate to severe active rheumatoid arthritis (RA); (2) Adult patients with active psoriatic arthritis (PsA); (3) Adult patients with moderate to severe active ulcerative colitis (UC); (3) Active polyarticular juvenile idiopathic patients aged 2 years and older Patients with arthritis (pcJIA) and juvenile PsA
.

Tofacitinib mechanism of action: inhibition of JAK (picture from document PMID: 24883332)

Now, the CHMP’s opinions will be submitted to the European Commission (EC) for review, which is expected to make a final review decision on the abrocitinib and Xeljanz applications by the end of this year
.

If the EC grants centralized marketing authorization, it will be valid in all EU member states, Iceland, Liechtenstein, and Norway

Dr.
Michael Corbo, Chief Development Officer of Inflammation and Immunology, Pfizer Global Product Development, said: “The positive recommendations of CHMP bring us closer to the goal of helping patients with moderate to severe atopic dermatitis in Europe alleviate symptoms
.

We look forward to working with the European Commission.

Dr.
Diamant Thaci of the Comprehensive Center for Inflammation Medicine at the University of Lubeck, Germany, said: “Atopic dermatitis is an inflammatory disease that affects the daily lives of millions of people
.

Compared with placebo, abrocitinib has shown significant efficacy, including relief Iconic chronic pruritus, skin lesion removal, rapid improvement in the extent and severity of the disease, and a good benefit risk profile

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

Atopic dermatitis (AD) is a chronic skin disease characterized by skin inflammation and skin barrier defects.
It is characterized by skin erythema, itching, hardening/papule formation, and exudation/scabbing
.

The disease is a serious, unpredictable, and usually debilitating skin disease that will have a significant impact on the daily lives of patients and their families

The active pharmaceutical ingredient of Cibinqo is abrocitinib, which is an oral small molecule that can selectively inhibit Janus kinase 1 (JAK1)
.

Inhibition of JAK1 is believed to regulate a variety of cytokines involved in the pathophysiological process of atopic dermatitis (AD), including interleukin (IL)-4, IL-13, IL-31, IL-22 and thymic stromal lymphocyte production Plain (TSLP)

In September of this year, Cibinqo was approved in the United Kingdom and Japan for the treatment of adolescents and adults with moderate to severe atopic dermatitis (AD) who are suitable for systemic treatment, have insufficient response to existing therapies, and are 12 years of age and older
.

At present, abrocitinib's listing application has been submitted to many countries and regions around the world for review, including the United States, Australia and the European Union

In a number of clinical trials, abrocitinib has a strong effect in relieving the symptoms and signs of AD, including rapidly reducing the symptoms of itching and removing skin lesions
.

In particular, in the head-to-head Phase 3 JADE DARE (B7451050) study, compared with the subcutaneous injection preparation Dupixent (Chinese trade name: Dabituo, generic name: dupilumab), abrocitinib was evaluated in every evaluation All of the curative effect indicators are statistically superior

Original source: Pfizer's Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis

Original source: Pfizer's Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis