AstraZeneca's severe asthma treatment gets EU approval

Drugmaker AstraZeneca said on Wednesday that Tezspire, its severe asthma treatment, had received EU approval for use as an add-on maintenance treatment in patients 12 years and older.

AstraZeneca stated Tezspire was the "first and only" biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations

The FTSE 100-listed group said the European Commission's approval was based on results from its PATHFINDER clinical trial programme, in which Tezspire demonstrated "superiority across every primary and key secondary endpoint" in patients with severe asthma. It also follows a recommendation by The Committee for Medicinal Products for Human Use of the European Medicines Agency in July.

Mene Pangalos, AZN's executive vice president of biopharmaceuticals R&D, said: "Severe asthma continues to have a debilitating impact for people living with the disease, with many patients experiencing frequent exacerbations, an increased risk of hospitalisation and a significantly reduced quality of life.

"Tezspire is now the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation and we look forward to bringing this important medicine to patients as quickly as possible."

Reporting by Iain Gilbert at Sharecast.com