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AstraZeneca To Challenge GSK After Clinching Lupus Drug Approval

FDA Gives Green Light To Saphnelo

 
• By Kevin Grogan

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.

Sodertalje, Sweden - April 27, 2014: Three purple flags with the logo for Atrazeneca flying in the wind on top of the flagpoles against the blue sky.
• Source: Archive

AstraZeneca PLC's commercial teams are all set for the US launch of anifrolumab, the first medicine to be approved in over a decade for lupus, at the end of August, the company's biopharmaceuticals head has told Scrip.

Ruud Dobber said that the US Food and Drug Administration's approval of anifrolumab, which has the brand name Saphnelo, for...

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