AstraZeneca’s (AZ) Tezspire (tezepelumab) has been approved by the European Commission (EC) for use as an add-on maintenance treatment in patients 12 years and older with severe asthma, the company announced.
The approval is specifically for patients who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product.
The EC’s decision follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July 2022, and makes Tezspire the first and only biologic approved in Europe for patients with severe asthma with no phenotype of biomarker limitation.
Positive results from AZ’s PATHFINDER clinical trial programme were the driving force behind the approval, which included the pivotal NAVIGATOR phase 3 trial in which Tezspire demonstrated ‘superiority across every primary and key secondary endpoint’ in patients with severe asthma, compared to placebo, when added to standard therapy
Moreover, Tezspire ‘consistently and significantly’ reduced asthma exacerbations across the PATHWAY phase 2 and the NAVIGATOR phase 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).
In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia and injection site reactions, the company noted.
Asthma affects approximately 14 million people in the EU and an estimated 339 million people worldwide, with up to 10% of asthma patients living with severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids (OCS), many severe asthma patients remain uncontrolled.
Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life. Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalisations
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ, 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 being developed by AZ in collaboration with Amgen as a first-in-class human monoclonal antibody, and has been approved in the US and other countries for the treatment of severe asthma, and regulatory reviews are ongoing in additional countries around the world.