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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval