UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its interleukin-5 (IL-5)-targeted antibody, Fasenra (benralizumab), for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal disease. The approval comes on the heels of the positive MANDARA Phase III trial results, which were published in The New England Journal of Medicine , demonstrating non-inferiority to mepolizumab, the only other biologic treatment for EGPA.
The MANDARA trial, a randomized, double-blinded, active-controlled study, included patients with relapsing or refractory EGPA. Fasenra’s high response rates and the ability to help patients taper off oral corticosteroids present a significant advancement in the treatment of this rare disease. This latest approval further solidifies AstraZeneca’s commitment to addressing unmet needs in rare diseases and follows the drug’s previous approval for severe eosinophilic asthma in 2017. – Flcube.com
