Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc.
The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy.
The approval comes as a group of potential rivals from the likes of Biogen Inc., Aurinia Pharmaceuticals Inc. and Remegen Ltd. are also approaching the market.
But it’s not been plain sailing for Astrazeneca to get this drug approved: The first big phase III trial failed before anifrolumab’s fortunes were saved in June last year with positive data from the second late-stage trial.
The approval sets up a face-off with GSK, which has been marketing its Benlysta (belimumab) in SLE since 2011.