Amgen and AstraZeneca's TEZSPIRE Receives FDA Approval for Nasal Inflammation Treatment

Amgen and AstraZeneca's TEZSPIRE has been approved by the FDA for use as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps in adults and pediatric patients aged 12 and older. TEZSPIRE targets thymic stromal lymphopoietin (TSLP) and is the first biologic approved for this condition, which affects approximately 320 million people globally. The approval expands TEZSPIRE's indication to a second epithelial-driven inflammatory disease.

The U.S. Food and Drug Administration (FDA) has approved Amgen's TEZSPIRE (tezepelumab-ekko) as an add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older. This approval marks the second indication for TEZSPIRE, which was previously approved for severe asthma, according to an Investing.com report.

TEZSPIRE targets thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that initiates inflammatory responses. This approval expands TEZSPIRE's indication to a second epithelial-driven inflammatory disease. CRSwNP affects up to approximately 320 million people worldwide and is characterized by persistent inflammation and benign polyp growths within the nasal cavity, as reported in a Healio article.

The FDA approval was based on results from the WAYPOINT Phase III trial, which demonstrated that TEZSPIRE significantly reduced nasal polyp severity and nearly eliminated the need for surgery while reducing systemic corticosteroid use compared to placebo. The safety profile in the trial was consistent with TEZSPIRE’s established profile in severe asthma. The most frequently reported adverse events were COVID-19, nasopharyngitis, and upper respiratory tract infection, as noted by Investing.com.

This approval could further boost Amgen’s already impressive revenue growth of 12.9% over the last twelve months, with total revenue reaching $34.9 billion. Regulatory applications for the CRSwNP indication are currently under review in Europe, China, Japan, and several other countries, Investing.com reported.