AstraZeneca's Saphnelo receives EU approval

AstraZeneca said Saphnelo was the first biologic for SLE approved in Europe with an indication that was not restricted to patients with a high degree of disease activity. The FTSE 100-listed firm noted that the approval by the European Commission was based on results from Saphnelo's clinical development programme, including its TULIP Phase III trials and the MUSE Phase II trial.

Saphnelo was also recently approved for the treatment of SLE in the US, Japan and Canada, with regulatory reviews also ongoing in additional countries.

AstraZeneca's vice president of biopharmaceuticals R&D, Mike Pangalos, said: "Saphnelo is the first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade and is the only biologic not restricted to patients with a high degree of disease activity. Saphnelo has demonstrated clinically meaningful benefits and we look forward to bringing it to patients as quickly as possible."