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.
Pfizer and BioNTech granted US EUA for booster dose of their COVID-19 vaccine in children 5 to 11
New data from Sanofi's oncology pipeline and portfolio to be presented at 2022 ASCO Annual Meeting
Vertex awards USD50m in grants to to JDRF, Mass General and Year Up
UK Grants Licence for Teva's Ophthalmology Biosimilar Ongavia
First Patient Dosed in Phase 1 Trial to Test Cancer-Killing Oncolytic Virus Against Solid Tumors
AbbVie to present gastroenterology portfolio and pipeline at Digestive Disease Week(R)
Wysa Receives FDA Breakthrough Device Designation for AI-led Mental Health Conversational Agent
Kintor Pharmaceutical added to MSCI China Index
Inmagene Biopharmaceuticals' IMG-004 investigational new drug application receives US FDA approval