Saphnelo approved in the EU for sc self-administration

UK pharma major AstraZeneca (LSE: AZN) today revealed that Saphnelo (anifrolumab) has been approved in the European Union (EU) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.

The approval by the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and was based on the positive results from the Phase III TULIP-SC trial. In the trial, subcutaneous (SC) administration of Saphnelo is the cornerstone of AstraZeneca’s immunology portfolio and continues its rapid growth in the USA, European Union and Japan as only the second approved medicine for SLE in 60 years.

Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe, active, autoantibody-positive SLE while receiving standard therapy.