AstraZeneca, Amgen drug Tezspire wins EU approval for chronic nasal condition

AstraZeneca PLC and Amgen Inc. said Wednesday their drug Tezspire has been approved in the European Union to treat a chronic inflammatory nasal condition.

The European Commission cleared the drug as an add-on therapy for adults with severe chronic rhinosinusitis with nasal polyps who have not responded adequately to standard treatments, the companies said.

The approval was based on results from a late-stage trial where Tezspire showed a significant reduction in nasal polyp severity and nearly eliminated the need for surgery compared to a placebo, according to the company.

The decision follows the drug's recent approval for the same condition in the U.S. in October.

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

"In Europe, we know that nearly half of patients with chronic rhinosinusitis with nasal polyps remain uncontrolled despite treatment with standard of care, which is why today's approval of Tezspire is such an important step forward in this challenging disease," said Ruud Dobber, an executive vice president at AstraZeneca.

The condition, which involves benign growths in the nasal cavity, affects approximately 320 million people worldwide.

Regulatory applications for the new indication are also under review in China, Japan, and other countries, the company said.