Amgen(US:AMGN) Prnewswire·2025-10-17 20:00Core Insights - The FDA has approved TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older, marking it as the first biologic targeting thymic stromal lymphopoietin (TSLP) for this condition [1][3][6] Group 1: Product Approval and Indication - TEZSPIRE is now indicated for both severe asthma and CRSwNP, expanding its therapeutic applications [6][1] - The approval is based on data from the WAYPOINT Phase III trial, which demonstrated significant efficacy in reducing nasal polyp severity and the need for surgery [3][18] Group 2: Disease Impact and Patient Need - CRSwNP affects approximately 320 million people globally, leading to persistent inflammation and symptoms like airflow obstruction and impaired sense of smell [2][4] - Current treatments often fail to provide lasting relief, highlighting the need for new therapeutic options like TEZSPIRE [2][4] Group 3: Clinical Trial Results - In the WAYPOINT trial, TEZSPIRE showed a statistically significant reduction in nasal polyp size and a near-elimination of surgery necessity compared to placebo [3][19] - Key secondary endpoints included improvements in nasal congestion, loss of smell, and overall quality of life [19][3] Group 4: Safety and Tolerability - The safety profile of TEZSPIRE in the WAYPOINT trial was consistent with its established profile in severe asthma, with common adverse events including COVID-19 and upper respiratory infections [4][7] - Hypersensitivity reactions were noted, emphasizing the importance of monitoring during treatment [7][4] Group 5: Future Prospects - Regulatory applications for TEZSPIRE are under review in Europe, China, Japan, and other countries, indicating potential for broader market access [5][1] - The collaboration between Amgen and AstraZeneca continues to evolve, with both companies sharing costs and profits equally for TEZSPIRE [20][1]