AstraZeneca To Challenge GSK After Clinching Lupus Drug Approval
FDA Gives Green Light To Saphnelo
Fears that US regulators would take issue with AstraZeneca's decision to change the endpoints of a second pivotal trial for anifrolumab were unfounded and the first-in-class type I interferon inhibitor is the first new treatment for systemic lupus erythematosus in more than 10 years.
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Despite a troubled history of JAK inhibitors in lupus trials, AbbVie’s Rinvoq has hit the mark in a mid-stage study of the condition, shifting focus to a pivotal program that could expand the blockbuster drug’s reach.
A Phase II study testing the TYK2 inhibitor in systemic lupus erythematosus met the primary endpoint. CMO Samit Hirawat talked to Scrip about the data and future development.
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.