US FDA Approves Tezspire for Chronic Rhinosinusitis with Nasal Polyps
The U.S. Food and Drug Administration (FDA) has approved Tezspire (tezepelumab) for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and pediatric patients aged 12 and older.
AstraZeneca and Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Tezspire (tezepelumab) for patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the first and only biologic targeting thymic stromal lymphopoietin (TSLP) approved for CRSwNP, addressing a condition characterized by epithelial-driven inflammation.
The FDA approval follows positive results from the Phase III WAYPOINT trial, which demonstrated that Tezspire significantly reduced nasal polyp severity compared to placebo. The trial also showed a near-elimination of the need for surgery and a substantial reduction in systemic corticosteroid use among patients treated with Tezspire.
CRSwNP affects up to 320 million people globally, causing persistent inflammation, nasal polyps, congestion, and loss of smell. Current treatment options, including corticosteroids and sinus surgery, often provide incomplete or temporary relief for many individuals. Physician Joseph Han noted that Tezspire offers a novel treatment option targeting the inflammatory cascade.
Tezspire is already approved for severe asthma in the U.S., EU, and over 60 countries. The companies have also submitted regulatory applications for CRSwNP in the EU, China, and Japan. The safety profile observed in the WAYPOINT trial was consistent with Tezspire's established safety profile.