FDA rejects approval of AstraZeneca's new application for Fasenra

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AstraZeneca's Fasenra (benralizumab) hits a snag as it tries to expand its indications

Recently, the FDA issued a Complete Response Letter (Complete Response Letter) to AstraZeneca Fasenra's application for the treatment of nasal polyps, and rejected the application because the results of the Phase III trial OSTRO data were not convincing enough

In the clinical trial study called OSTRO, Fasenra met two co-primary endpoints and demonstrated a strong safety profile

Chronic rhinosinusitis with nasal polyps is a common disorder characterized by inflammation of the lining of the nose and sinus cavities

Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and then attracts killer cells to the site to reduce polyps and inflammation

According to AstraZeneca's annual report, Fasenra's sales will reach $1.

AstraZeneca had hoped to take a slice of the market share of formidable rival Dupixent, but this time the FDA's rejection messenger Fasenra is at a disadvantage in the competition for anti-inflammatory biologics

Currently, AstraZeneca remains committed to bringing Fasenra's nasal polyp indication to market

Reference source: Sanofi Long wait for pivotal data on Sanofi's oral SERD ends in failure