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Tezspire recommended for EU approval in nasal polyps
['John Pinching']
PharmaTimes
Tezspire (tezepelumab) has received a positive opinion from the CHMP for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
The recommendation supports EU approval of a new option for patients with moderate to severe disease who have not responded to conventional or biologic therapies.
The decision is based on results from the phase 3 WAYPOINT trial, which showed Tezspire significantly reduced nasal polyp severity and congestion compared with placebo.
At week 52, patients receiving Tezspire saw a mean reduction in Nasal Polyp Score of -2.08 and in Nasal Congestion Score of -1.04.
Tezspire is already approved for severe asthma in the US, EU, Japan and over 60 countries.
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