AstraZeneca's Tezspire for severe asthma gets green light in EU

The European Commission has followed the lead of the US FDA and approved AstraZeneca's Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease.

Tezspire (tezepelumab) has been cleared for use in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product, based on the results of the PATHFINDER clinical trial programme.

Approval of the first-in-class TSLP inhibitor wasn't considered a shoo-in, as Tezspire failed one of its two pivotal phase 3 trials, but the Commission and FDA have concluded that the totality of the data – which also included a positive phase 2b study – was enough to show efficacy and safety.

AZ and partner Amgen – which makes the drug and records commercial sales for the drug in the US – are hoping to build a market for the drug as an alternative to current biologics for severe asthma, which can only be prescribed to patients with specific biomarkers.

The current therapies include Sanofi/Regeneron's IL-4/IL-13 inhibitor Dupixent (dupilumab) and AZ's own IL-5 inhibitor Fasenra (benralizumab), which competes with GlaxoSmithKline's Nucala (mepolizumab) and Teva's Cinqaero (reslizumab), which are restricted for use in certain patients, such as those with high levels of eosinophils.

Around 60% of patients with uncontrolled asthma don't have high eosinophil levels, however, and that has led some analysts to predict blockbuster sales for Tezspire. After its US approval, analysts at Piper Sandler predicted sales would reach $500 million in 2023, and top $1 billion by 2025, while Jefferies is reckoning on peak sales of $1.5 billion or more.

Dupixent is considered the main competitor, as it is approved for moderate and severe asthma patients, but showed limited activity in severe asthma patients with low eosinophil levels. AZ and Amgen's 'all-comer' label could make it the first option for people at the severe end of the asthma spectrum who struggle to control symptoms.

So far, take-up of the drug is running ahead of some analyst expectations. Piper Sandler were looking at 2022 sales of around $50 million, but Amgen recorded $36 million in sales in the first six months of the year, setting it on course to top that prediction.

That performance has come on the back of a list price of around $47,000 per year ahead of discounts or rebates, well above a "placeholder" price of $28,000 that the Institute for Clinical and Economic Review (ICER) in the US said would be too high to be cost-effective. Pricing in Europe will of course depend on reimbursement negotiations with national authorities.

"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," commented Mene Pangalos, head of biopharma R&D at AZ.

"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," he added.