AstraZeneca: Fasenra Approved By FDA To Treat Eosinophilic Granulomatosis With Polyangiitis

(RTTNews) - AstraZeneca PLC (AZN, AZN.L) announced Wednesday that its Fasenra (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis or EGPA.

EGPA, formerly known as Churg-Strauss Syndrome, is a rare, immune-mediated vasculitis that is caused by inflammation of small to medium-sized blood vessels, which can result in damage to multiple organs, and can be fatal without treatment.

The approval by the US Food and Drug Administration was based on positive results from the MANDARA Phase III trial that compared the efficacy and safety of Fasenra to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.

In the MANDARA trial, which was the first head-to-head non-inferiority trial of biologics in patients with EGPA, patients were randomised to receive either a single 30 mg subcutaneous injection of Fasenra, or three separate 100 mg subcutaneous injections of mepolizumab every four weeks.

In the trial, nearly 60% of Fasenra-treated patients achieved remission which was comparable to mepolizumab-treated patients. Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids or OCS, compared to 26% in the mepolizumab arm.

Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries including the US, Japan, EU and China. It is also approved in children and adolescents ages six and above in the US and Japan.

The FDA granted Orphan Drug Designation for Fasenra for EGPA in 2018.

Joyce Kullman, Executive Director, Vasculitis Foundation said, "This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease."

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