July 20, 2023

Phase III TRuE-AD3 study of Opzelura meets primary endpoint in atopic dermatitis – Incyte

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least 2 to <12 years) with atopic dermatitis (AD). The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success […]

admin Health 0 36 sec read
January 4, 2022

Cibinqo recommended for approval by CHMP for atopic dermatitis – Pfizer

Pfizer 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 Cibinqo (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 […]

admin Health 0 22 sec read
October 9, 2021

FDA approves Opzelura cream for mild to moderate atopic dermatitis – Incyte

Incyte announced that the FDA has approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a […]

admin Health 0 1 min read
September 22, 2021

UK MHRA grants marketing authorisation for Cibinqo for adults and adolescents with moderate to severe atopic dermatitis – Pfizer

Pfizer Inc. 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 […]

admin Health 0 26 sec read

Recent Posts

Meta

Categories

Archives

Recent Comments