AstraZeneca drug wins EU backing after a recent setback

AstraZeneca PLC said its drug Tezspire, developed with Amgen Inc., won a key European regulatory backing for a new use, a positive development for the company following recent trial setbacks.

The European Medicines Agency's advisory panel recommended the drug for treating adults with chronic rhinosinusitis with nasal polyps, a chronic inflammatory condition.

The positive opinion was based on a late-stage trial where Tezspire showed a statistically significant reduction in nasal polyp severity and congestion compared to a placebo, the company said.

According to AstraZeneca, data from the trial also showed the treatment nearly eliminated the need for surgery and significantly reduced the use of systemic corticosteroids.

"The CHMP recommendation brings us closer to offering Tezspire to patients across the EU who face the daily challenges of this disruptive and difficult-to-treat disease," said Ruud Dobber, an executive vice president at AstraZeneca.

The news follows recent late-stage trial failures for the British drugmaker, including for an experimental rare-disease drug and a separate treatment for chronic obstructive pulmonary disease.

Tezspire is already approved for treating severe asthma in more than 60 countries, including the U.S. and EU.

The company said regulatory applications for the new use are also under review in the U.S., China, and Japan.