AbbVie (NYSE: ABBV), a United States-based biopharmaceutical company, announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for its RINVOQ (upadacitinib) to treat moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to earlier treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.
RINVOQ 15mg once daily can be initiated in adults and children 12 years of age and older weighing around 40kg. Dose is likely to be increased to 30mg once daily in these children and adults less than 65 years of age who do not achieve an adequate response.
Abbvie says that the FDA approval is supported by efficiency and safety data from one of the largest registrational Phase three programs for atopic dermatitis with over 2,500 patients assessed across three studies.
Lupin announces receipt of US FDA tentative approval for Apixaban Oral Suspension
QIAGEN completes US QIAstat-Dx bloodstream infection portfolio with FDA clearance
Innovent expands global Phase 3 study of IBI363/TAK-928 to include non-squamous NSCLC
FDA approves WELIREG and LENVIMA combination for previously treated advanced renal cell carcinoma
AstraZeneca's IMFINZI combination receives US Priority Review for muscle-invasive bladder cancer
XtalPi submits US FDA IND application for KQTD-126 in chronic intestinal pain
Revvity launches IVDR-certified solution for early detection of type 1 diabetes
FDA Advisory Committee votes in favour of GRAIL's Galleri multi-cancer early detection test
AstraZeneca's Trixeo Aerosphere approved in EU for asthma maintenance treatment
AbbVie secures EU approval for RINVOQ in polyarticular juvenile idiopathic arthritis