medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended approval of anifrolumab for the treatment of patients with moderate-to-severe active systemic lupus erythematosus (SLE) despite standard therapy.
This announcement follows FDA approval of the type I interferon receptor antagonist for this population in July 2021.
The benefits of anifrolumab were shown in the phase 3 TULIP-1 and TULIP-2 trials, which demonstrated an overall improvement in clinical measures with anifrolumab versus placebo, even though the TULIP-1 trial did not meet its primary endpoint.
Click through to read more about the TULIP studies and the importance of trial endpoints
Anifrolumab will be available in the European Union as a 300 mg concentrate for infusion in a solution. The EMA notes that the most common adverse events seen with anifrolumab are upper respiratory tract infection, bronchitis, infusion-related reaction, and herpes zoster.
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