LONDON (dpa-AFX) - AstraZeneca PLC (AZN, AZN.L, ZEG.DE, AZN.ST) said its Saphnelo - anifrolumab - has been approved in the European Union for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus on top of standard therapy. The approval by the European Commission follows the positive opinion from the CHMP and was based on the positive results from the Phase III TULIP-SC trial.
The company noted that the subcutaneous administration of Saphnelo is under regulatory review in several other countries around the world including the US and Japan.
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