AstraZeneca And Amgen’s Tezspire Approved By FDA For Chronic Rhinosinusitis With Nasal Polyps

AstraZeneca and Amgen have received U.S. FDA approval for Tezspire (tezepelumab) as an add-on maintenance treatment for adults and adolescents aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This marks Tezspire as the first and only biologic that targets thymic stromal lymphopoietin (TSLP) to gain approval for this condition, offering a new treatment option for patients who do not respond adequately to existing therapies.

Dr. Joseph Han, Vice Chair of Department of Otolaryngology - Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the WAYPOINT trial, said: “Over 320 million lives globally are disrupted by chronic rhinosinusitis with nasal polyps. The FDA approval of Tezspire brings forward a new treatment option that has demonstrated rapid and sustained symptom improvement, nearly eliminating the need for future surgeries and significantly reducing systemic steroid use. By targeting TSLP at the top of the inflammatory cascade, Tezspire offers a novel option for patients who continue to endure the disruption of this disease despite available treatments.”

The FDA’s decision was supported by results from the Phase III WAYPOINT trial, presented at the 2025 AAAAI/WAO Joint Congress and published in The New England Journal of Medicine. The data showed that Tezspire significantly reduced nasal polyp severity, minimized the need for surgery, and lowered systemic corticosteroid use compared to placebo. The treatment’s safety profile in the study was consistent with its known tolerability, with the most common side effects being COVID-19, nasopharyngitis, and upper respiratory tract infection.

Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA), said: “Chronic rhinosinusitis with nasal polyps is a persistent and often-overlooked disease that can significantly impact daily life, robbing patients of their ability to breathe without congestion and full sense of smell. This approval introduces an innovative treatment option for patients with the potential to help address the ongoing cycle of debilitating symptoms, surgeries and systemic steroid use.”

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a debilitating inflammatory disorder that affects up to 320 million people worldwide, leading to nasal obstruction, congestion, and loss of smell. Many patients require repeated surgeries or long-term corticosteroid therapy, which often fail to provide sustained relief. Tezspire’s approval in the U.S. represents a major advancement in CRSwNP care. Meanwhile, the European Medicines Agency’s CHMP has issued a positive opinion for approval in the EU, with additional regulatory reviews ongoing in China, Japan, and other countries.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: “Today’s approval of Tezspire in chronic rhinosinusitis with nasal polyps expands the reach of this innovative treatment option to patients living with an epithelial-driven inflammatory disease beyond severe asthma. Building on the widespread, established use of Tezspire in severe asthma, this exciting milestone now reinforces its unique mechanism of action across both the upper and lower airways and reflects our commitment to transforming care for patients who face the daily burden of chronic respiratory and immune-mediated diseases.”