New FDA Approvals: FDA Grants Another Indication to Rinvoq

Oct. 21: The FDA granted another indication to AbbVie Inc.’s Rinvoq (upadacitinib) for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors. The agency first approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. Dosing of the extended-release tablets for the newest indication is 15 mg once daily. The wholesale acquisition cost (WAC) of a 30-day supply is $5,671.26.

Oct. 21: The FDA approved AstraZeneca’s Imjudo (tremelimumab-actl) in combination with the company’s Imfinzi (durvalumab) for the treatment of adults with unresectable hepatocellular carcinoma. Dosing for people weighing at least 30 kg is 300 mg of Imjudo, a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, via intravenous infusion one plus 1,500 mg of Imfinzi, a programmed death-ligand 1 (PD-L1) inhibitor, also via intravenous infusion at cycle one/day and then Imfinzi as a single agent every four weeks. For those weighing less than 30 kg, dosing is 4 mg/kg of Imjudo plus 20 mg/kg of Imfinzi at cycle one/day one and then Imfinzi every four weeks.