Anifrolumab set for EMA approval for moderate-to-severe SLE
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.
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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