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Abrocitinib

Generic Name
Abrocitinib
Brand Names
Cibinqo
Drug Type
Small Molecule
Chemical Formula
C14H21N5O2S
CAS Number
1622902-68-4
Unique Ingredient Identifier
73SM5SF3OR
Background

Abrocitinib is an oral small-molecule inhibitor of Janus kinase 1 (JAK1). Janus kinases are intracellular enzymes involved in transduction pathways that regulate hematopoiesis and immune cell function. The Janus kinase (JAK)–signal transducer and activator of transcription (STAT) signalling pathway plays a central role in the pathogenesis of a variety of autoimmune and inflammatory diseases, including atopic dermatitis, a chronic inflammatory skin disease with complex pathogenesis. Atopic dermatitis is characterized by epidermal hyperplasia, skin barrier dysfunction, and the aberrant activation of immune cells. Patients with moderate-to-severe atopic dermatitis report reduced quality of life and often face limited treatment options. JAK inhibitors recently attracted more attention as potential treatments for inflammatory disorders, as JAK inhibition is associated with rapid and sustained anti-inflammatory efects.

Abrocitinib was approved by the European Commission on December 10, 2021, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. On January 14, 2022, the FDA approved abrocitinib for the treatment of refractory, moderate-to-severe AD in adults whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Health Canada also approved the use of abrocitinib in pediatric patients 12 years and older.

Indication

Abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. In the US, it is indicated to treat refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable.

Abrocitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

Associated Conditions
Severe Atopic Dermatitis, Moderate Atopic dermatitis, Moderate, refractory Atopic dermatitis, Refractory, severe Atopic Dermatitis

Sanofi's Amlitelimab Shows Promising Results in Atopic Dermatitis Trial Following $1.45bn Kymab Acquisition

• Sanofi's amlitelimab (formerly KY1005), acquired through its $1.45 billion Kymab purchase, demonstrated significant efficacy in a Phase 2a trial for moderate to severe atopic dermatitis with an 80% improvement in EASI scores at the low dose. • The OX40 ligand-targeting antibody showed durable effects, with two-thirds of patients maintaining clear or almost clear skin 24 weeks after the final dose, positioning it as a potential complement to Sanofi's blockbuster Dupixent. • Despite increasing competition in the atopic dermatitis market from biologics and JAK inhibitors, Sanofi is advancing amlitelimab to Phase 2b trials, emphasizing the need for diverse treatment options for this challenging condition.

FDA Approves Opzelura as First Topical JAK Inhibitor for Atopic Dermatitis

• Incyte's Opzelura (ruxolitinib) cream has received FDA approval as the first topical JAK inhibitor for treating atopic dermatitis in adolescents and adults who failed other topical therapies. • Clinical trials demonstrated significant efficacy with 51-54% of patients achieving treatment success at week 8, compared to 8-15% in control groups. • Despite its topical application, Opzelura carries a boxed warning for serious infections and cardiovascular risks, potentially impacting its projected $1 billion peak sales potential.

Innovative Therapies for Schizophrenia, Atopic Dermatitis, Hepatitis B, and SLE Highlighted at CIIE

• Johnson & Johnson launched INVEGA HAFYERA in China, a twice-yearly injection for schizophrenia treatment, marking its debut after being introduced at CIIE 2022. • Pfizer showcased Cibinqo and Staquis as innovative therapies for atopic dermatitis (AD), addressing a common immuno-inflammatory disease affecting millions in China. • GSK's Bepirovirsen, a potential 'functional cure' for chronic hepatitis B, is undergoing Phase III clinical studies and has received breakthrough therapy designation in China. • GSK also presented its innovative therapy for systemic lupus erythematosus (SLE) and initiated a public welfare project to improve SLE diagnosis, treatment, and patient support.

FDA Approves Eli Lilly's Ebglyss (lebrikizumab) for Eczema Treatment in Adults and Children

• The FDA has approved Eli Lilly's Ebglyss (lebrikizumab) for treating moderate-to-severe eczema in adults and children aged 12 and older. • Ebglyss, a monoclonal antibody targeting the IL-13 protein, offers a new first-line biologic option when topical treatments are insufficient. • Clinical trials involving over 1,000 patients demonstrated Ebglyss's efficacy in controlling eczema symptoms, with a less frequent dosing schedule than some alternatives. • The approval provides a new treatment option for the nearly 16.5 million adults in the U.S. affected by eczema, with availability expected in the coming weeks.

Emerging Therapies Nemolizumab and Lebrikizumab Poised to Reshape Atopic Dermatitis Market

• Galderma's nemolizumab and Eli Lilly's lebrikizumab are anticipated to significantly alter dermatologist perceptions and treatment strategies for atopic dermatitis. • Adbry has shown substantial growth and now rivals Rinvoq, which has seen its usage stabilize since 2022, indicating a shift in treatment preferences. • Dermatologists estimate that advanced systemic treatments are now used in two-fifths of adult atopic dermatitis patients, reflecting a growing demand for effective therapies. • Nemolizumab's mechanism of action targeting IL-31 is increasingly favored over IL-13, potentially driving its adoption, especially for patients with severe itch.
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