Tezspire wins EU approval for chronic rhinosinusitis with nasal polyps

AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN) received European Union approval for Tezspire as an add-on therapy for adult patients with severe chronic rhinosinusitis with nasal polyps who have not responded adequately to standard treatments.

The European Commission approved the drug based on results from the WAYPOINT Phase III trial, which demonstrated reduced nasal polyp severity and nasal congestion compared to placebo. The trial also showed near-elimination of the need for surgery and reduced systematic corticosteroid use.

Tezspire will be used with intranasal corticosteroids for patients who have not adequately responded to systemic corticosteroids or surgery. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use.

Chronic rhinosinusitis with nasal polyps affects approximately 320 million people worldwide and is characterized by inflammation and polyp growths within the nasal cavity. The condition causes airflow obstruction, congestion and impaired sense of smell. Nearly half of patients diagnosed with the condition in Europe remain uncontrolled with current treatments.

The drug's safety profile in the trial was consistent with its known characteristics. The most frequently reported adverse events were COVID-19, nasopharyngitis and upper respiratory tract infection.

Tezspire received U.S. approval for the same indication in patients aged 12 years and older. Regulatory applications are under review in China, Japan and other countries. The drug is already approved for severe asthma treatment in the U.S., EU, Japan and more than 60 countries globally.

The medication targets thymic stromal lymphopoietin, addressing epithelial-driven inflammation. Trial results were presented at the American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress and published in The New England Journal of Medicine.

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