AstraZeneca PLC on Wednesday announced Fasenra has been approved in the US to treat adult patients with eosinophilic granulomatosis with polyangiitis, or EGPA.
The Cambridge, England-based biopharmaceutical company said the US Food & Drug Administration granted approval to Fansenra, or benralizumab, following ‘positive’ results from the MANDARA Phase III trial published in The New England Journal of Medicine.
EPGA is a rare, immune-mediated vasculitis that can result in damage to multiple organs. Without treatment, the condition can be fatal.
The trial compared the efficacy and safety of Fansera with the only other currently approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EPGA.
Nearly 60% of Fasenra-treated patients achieved remission in the trial, which was comparable to the results achieved in mepolizumab-treated patients. Additionally, 41% of Fansera-treated patients fully tapered off oral corticosteriods.
Approximately half of EGPA patients also have adult-onset severe eosinophilic asthma, or SEA, for which Fasenra is only the second biologic approved treatment. Fasenra is now approved as an add-on maintenance treatment for SEA in more than 80 countries.
Michael Wechsler, professor of medicine & director of The Asthma Institute at National Jewish Health, said: ‘This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms. Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EBPA patients, but benralizumab can also help patients taper off steroid therapy.’
Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals business unit, said: ‘Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA. Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.’
Shares in AstraZeneca were down 0.9% at 11,864.26 pence each in London on Wednesday morning.
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