EU Approves AstraZeneca’s Lupus Drug Saphnelo
The European Union has approved AstraZeneca’s lupus drug Saphnelo (anifrolumab), a first-in-class type 1 interferon receptor antibody as an add-on therapy for the treatment of severe, active autoantibody-positive systemic lupus erythematosus, despite receiving standard therapy.
Saphnelo will now begin competing with GlaxoSmithKline’s Benlysta (belimumab) for the treatment of moderate-to-severe systemic lupus erythematosus.
Saphnelo met primary endpoints in recent phase 2 and 3 trials, although it missed key endpoints in a second phase 3 trial, the company said.
The drug was recently approved in the U.S., Japan and Canada, and is undergoing review in several other countries.