Overview
- The EMA’s CHMP issued a positive opinion recommending EU approval of Tezspire (tezepelumab) for adults with chronic rhinosinusitis with nasal polyps.
- The recommendation rests on the Phase III WAYPOINT trial, which met co-primary endpoints at week 52 versus placebo.
- Patients on Tezspire saw a mean Nasal Polyp Score change of −2.08 and a Nasal Congestion Score change of −1.04.
- WAYPOINT also reported a 98% reduction in the need for surgery and an 89% reduction in systemic corticosteroid use, with safety consistent with the drug’s known profile.
- Tezspire is already approved for severe asthma in more than 60 countries, and CRSwNP regulatory reviews are underway in the US, China, Japan and other markets.