FDA Approves Amgen & AstraZeneca’s Drug for Severe Sinus Condition in Teens and Adults

The U.S. Food and Drug Administration (FDA) has expanded approval for Tezspire (tezepelumab-ekko), a drug co-developed by Amgen and AstraZeneca. Starting now, it can be used as a maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in people aged 12 and older. 

CRSwNP is a long-term sinus condition featuring inflammation and non-cancerous growths called nasal polyps. Symptoms include nasal blockage, loss of smell and pressure around the face. Previously, the drug was approved only for severe asthma.

The approval draws on late-stage trial results which showed Tezspire significantly reduced polyp size, eased congestion and cut surgery risk by nearly 98%. Oral steroid use dropped around 88% compared to a placebo. 

Analysts say Tezspire may outperform current treatments like Dupixent for some patients, thanks to its novel target — TSLP, a key protein in the inflammation pathway. 

Amgen’s global inflammation-head said the expansion “shows the versatility of TSLP inhibition beyond asthma”. The drug now offers an option for those who struggle with persistent sinus condition despite existing treatments. 

In short, this FDA decision broadens treatment access for teens and adults affected by a serious sinus illness. It also boosts Amgen and AstraZeneca’s presence in the broader inflammation-therapeutics space.