AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation

The FDA approved on Wednesday AstraZeneca Plc’s AZN Fasenra (benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.

The approval was based on data from the MANDARA Phase 3 trial published in The New England Journal of Medicine, which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, GSK Plc’s GSK Nucala (mepolizumab).

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MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.

In the trial, nearly 60% of Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.

Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).

The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.

Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra is the second biologic approved to treat this disease.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.

It is also approved in children and adolescents ages six and above in the U.S. and Japan.

Last month, the FDA approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.

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