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.
You may also be interested in...
Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Albert Roy, executive director of the clinical research arm of the Lupus Research Alliance, talked to Scrip about the outlook for lupus drug development.
The second Phase III TULIP trial for AstraZeneca’s anifrolumab has succeeded where the first failed by hitting a new primary endpoint in systemic lupus erythematosus.