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AstraZeneca PLC on Wednesday said its drug Tezspire has been approved in the European Union for the treatment of adult patients with chronic rhinosinusitis with nasal polyps. The Cambridge, England-based pharmaceuticals company said the approval follows a recommendation by the Committee for Medicinal Products for Human Use, which is part of the European Medicines Agency. The recommendation is based on Waypoint phase III trial results showing Tezspire reduced nasal polyp severity and nasal congestion, nearly eliminated the need for surgery and significantly reduced systemic corticosteroid use versus placebo. The approval comes a day after the US Food & Drug Administration approved Tezspire in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled severe chronic rhinosinusitis with nasal polyps. Tezspire is being developed by AstraZeneca in collaboration with Amgen Inc, a Thousand Oaks, California-based biotechnology company. Astrazeneca said regulatory applications are currently under review in the US, China, Japan and several other countries based on the trial. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and more than 60 countries across the globe. AstraZeneca said the safety profile and tolerability of Tezspire in the trial were consistent with the known profile of the medicine. Ruud Dobber, president of the BioPharmaceuticals Business Unit at AstraZeneca, said: ‘In Europe, we know that nearly half of patients with chronic rhinosinusitis with nasal polyps remain uncontrolled despite treatment with standard of care, which is why today’s approval of Tezspire is such an important step forward in this challenging disease. ‘This approval broadens Tezspire’s benefits beyond severe asthma and reinforces Tezspire’s innovative mechanism of action that targets thymic stromal lymphopoietin, uniquely addressing epithelial-driven inflammation at its source.’ Shares in AstraZeneca rose 0.2% to 12,520.00 pence on Wednesday morning in London. The wider FTSE 100 index was up 0.8%. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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