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Investing.com -- AstraZeneca and Amgen have received European Union approval for Tezspire as an add-on therapy for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who haven’t responded adequately to standard treatments.
The European Commission’s approval follows positive results from the WAYPOINT Phase III trial, which showed Tezspire significantly reduced nasal polyp severity and nasal congestion while nearly eliminating the need for surgery and reducing systemic corticosteroid use compared to placebo.
Dr. Oliver Pfaar, an investigator in the WAYPOINT trial and Chair at the University Hospital Marburg in Germany, said: "Chronic rhinosinusitis with nasal polyps is challenging to treat, as it often requires repeat surgeries and ongoing treatment with systemic corticosteroids, both of which can result in serious side effects. Tezepelumab’s approval in the EU means clinicians have an innovative new treatment option that has shown a clinically meaningful and significant reduction in nasal polyp size, symptom severity and the need for surgery and systemic corticosteroid use compared to placebo."
Ruud Dobber, Executive Vice President at AstraZeneca, noted that nearly half of European CRSwNP patients remain uncontrolled despite standard care treatments. The approval expands Tezspire’s benefits beyond severe asthma, highlighting its mechanism that targets thymic stromal lymphopoietin (TSLP) to address inflammation at its source.
CRSwNP affects approximately 320 million people worldwide. The condition causes benign polyp growths in the nasal cavity and symptoms including congestion and reduced sense of smell. Current therapies like systemic corticosteroids and repeated surgeries often fail to provide lasting relief.
The safety profile in the WAYPOINT trial aligned with Tezspire’s known profile, with the most common adverse events being COVID-19, nasopharyngitis and upper respiratory tract infection.
Tezspire was recently approved in the US for CRSwNP and is under regulatory review in China, Japan and several other countries. The drug is already approved for severe asthma in the US, EU, Japan and more than 60 countries globally.
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