LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Monday said its Fasenra has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) as an add-on treatment for adults having relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
EGPA is a rare form of vasculitis, inflammation of the blood vessels, that can result in damage to multiple organs.
CHMP's positive opinion was based on results from the MANDARA Phase III study which compared the efficacy and safety of Fasenra to GSK's mepolizumab, the only approved EGPA treatment, in patients with EGPA. In the study, nearly 60 percent of patients treated with Fasenra achieved remission which was comparable to mepolizumab-treated patients.
Fasenra was recently approved in the U.S. for the treatment of EGPA and is also approved as an add-on maintenance treatment for severe eosinophilic asthma in more than 80 countries including the U.S., Japan, EU and China.
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