AstraZeneca’s (AZ) Tezspire (tezepelumab) has been granted marketing authorisation in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA) for use as an add-on maintenance treatment for 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 MHRA’s decision follows the approval by the European Commission (EC) earlier in September for this same indication, and makes Tezspire the first and only biologic approved in Great Britain 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 reduced annualised rate of asthma exacerbations – the primary endpoint of the study – for patients with severe uncontrolled asthma versus placebo, when added to standard therapy.
The trial also met key secondary endpoints, with patients treated with Tezspire demonstrating improved lung function, as well as a reduction of asthma exacerbations associated with hospitalisation, compared to patients treated with placebo.
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 eight million people in the UK, 200,000 of which are living with severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids, 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.
Ed Piper, medical and scientific affairs director, AstraZeneca UK, said: “We are thrilled that the MHRA has authorised tezepelumab, a first-in-class biologic therapy that targets the top of the inflammatory cascade.
“Today’s milestone supports AZ’s overall ambition to reduce the risk of respiratory attacks in the UK through the use of effective, biologic treatments.”
Tezspire is being developed by AZ in collaboration with Amgen as a first-in-class human monoclonal antibody. It 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.