The United States Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for United States-based AbbVie's (NYSE:ABBV) upadacitinib intended for the treatment of adults and adolescents with moderate to severe atopic dermatitis, it was reported on Friday.
Reportedly, the Prescription Drug User Fee Act (PDUFA) action date has been extended to the early third quarter of 2021.
AbbVie had received an information request from the US FDA for an updated evaluation of the benefit-risk profile for the product in atopic dermatitis. The company has responded to the request and the FDA has informed the company that, as expected, it needs additional time for a complete review of the submission. The product is a JAK inhibitor that is being studied in various immune-mediated inflammatory diseases.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT