AstraZeneca's Tezspire Recommended for EU Approval for Chronic Sinus Condition

By Cristina Gallardo

AstraZeneca said that its Tezspire drug was recommended for approval in the European Union for the treatment of adults with chronic rhinosinusitis with nasal polyps.

The pharmaceutical company said Monday that the decision, made by the European Medicines Agency's Committee for Medical Products for Human Use, was based on the results from the Waypoint Phase 3 trial, which showed a significant reduction in the severity of the condition.

The trial also almost completely removed the need for surgery compared to a placebo, as well as reducing patients' reliance on oral corticosteroids, AstraZeneca added.

Chronic rhinosinusitis with nasal polyps is a chronic inflammatory condition that causes persistent inflammation and benign polyps within the nose that can obstruct airflow and impair the sense of smell and disrupt sleep. It affects about 320 million people worldwide.

The drug is also being reviewed for the treatment of the condition in the U.S., China, Japan and several other countries based on the results of the same trial. Tezspire is also used for the treatment of severe asthma.

Write to Cristina Gallardo at cristina.gallardo@wsj.com