- Asthma drug Tezspire recommended for approval
- Significant clinical benefit
- Regulatory applications in several countries
Pharmaceutical giant AstraZeneca (AZN) said Tezspire has received a positive recommendation for approval in the European Union for the treatment of adult patients with (CRSwNP) chronic rhinosinusitis with nasal polyps.
CRSwNP is a persistent chronic inflammatory condition with associated benign nasal polyp growths in the nasal cavity which can obstruct airflow and impair the sense of smell, taste and sleep.
The condition affects around 320 million people globally with nearly half of patients diagnosed with CRSwNP in Europe remaining uncontrolled where repeated sinus surgeries and standard care do not provide lasting relief.
Ruud Dobber, Executive Vice President and President at AstraZeneca said: The unique way Tezspire works means it addresses the multiple drivers of epithelial-driven inflammation associated with chronic rhinosinusitis with nasal polyps.
‘This pivotal milestone builds upon Tezspire's foundational impact in severe asthma and reinforces our commitment to transforming respiratory care ‘
CLEAR CLINICAL BENEFITS
The recommendation by the CHMP (Committee for Medicinal Products for Human Use) at the European Medicines Agency was based results from a late-stage clinical trial which showed a statistically significant and clinically meaningful reduction in nasal polyp severity, and nasal congestion.
Tezspire demonstrated a near-complete elimination of the need for surgery and ‘significantly’ reduced the need for anti-inflammatory medications compared with patients on placebo.
Regulatory applications are under review in the US, China, Japan and several other countries based on the same late-stage trial.
Tezspire, which was jointly developed with US pharmaceutical company Amgen (AMGN:NYSE) is currently approved for the treatment of severe asthma in the US, EU, and Joan as well as 60 other countries.
The treatment generated $1.2 billion of sales for AstraZeneca in 2024, while Amgen reported a 73% year-on-year increase to almost $1 billion.
In mid-morning trading AstraZeneca shares were down 4p or 0.3% to £112.96, taking 2025 gains to 6% compared with an 11.5% advance in the FTSE 100 index.
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