AstraZeneca says the European Commission has approved its prescription medicine Saphnelo as an add-on therapy for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE).
It said on Wednesday that the approval followed the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2021.
Saphnelo has also received regulatory approval in the U.S., Japan and Canada for the treatment of SLE and regulatory reviews are ongoing in additional countries.
Systemic lupus erythematosus is a complex autoimmune condition that can affect any organ and patients often experience inadequate disease control, long-term organ damage and poor health-related quality of life.
dpa
