 HomeNewsEU CHMP recommended approval: cibinqo(abrocitinib) for atopic dermatitis and xeljanz(tofacitinib) for ankylosing spondylitis.

EU CHMP recommended approval: cibinqo(abrocitinib) for atopic dermatitis and xeljanz(tofacitinib) for ankylosing spondylitis.

2021-10-25

Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The CHMP also adopted a positive opinion recommending an extension to the existing indications for XELJANZ® (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

XELJANZ® (tofacitinib) 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.

"The CHMP`s positive recommendation brings us closer to our goal of helping people living with moderate to severe atopic dermatitis in Europe find relief," said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. [We look forward to working with the European Commission and hope to soon provide abrocitinib to people in Europe and eventually to more people worldwide who are living with this debilitating disease, many of whom have limited treatment options today."

"Atopic dermatitis can be a debilitating condition that impacts the daily lives of millions of people," said Dr. Diamant Thaci, Comprehensive Center for Inflammation Medicine, University of Luebeck, Germany. [Abrocitinib has shown significant efficacy, including relief from the hallmark chronic itch, rapid improvements in skin clearance, extent and severity of disease versus placebo, and a favorable risk-benefit profile. If approved, abrocitinib may become an important new treatment option for patients living with moderate to severe atopic dermatitis."

Based on these CHMP recommendations, a decision by the European Commission, which authorizes marketing approval in the European Union, is expected on the abrocitinib and XELJANZ applications later this year. If granted by the European Commission, the centralized marketing authorizations would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.

The recommendation for abrocitinib is based on the results of five Phase 3 studies and a long-term extension study from a robust clinical trial program including more than 3,100 patients.

The recommendation for XELJANZ is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of XELJANZ twice daily versus placebo in 269 adult patients living with active AS.

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 HomeNewsEU CHMP recommended approval: cibinqo(abrocitinib) for atopic dermatitis and xeljanz(tofacitinib) for ankylosing spondylitis.

Shandong Haohong Biotechnology Co., Ltd.