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.
The data also showed Tezspire nearly eliminated the need for surgery, with a 98% reduction, and cut systemic corticosteroid use by 89%. The safety and tolerability profile was consistent with previous findings and with Tezspire’s use in severe asthma.
Dr Oliver Pfaar, investigator in the WAYPOINT trial, said: “This positive CHMP recommendation is very encouraging and if approved, tezepelumab will provide patients and clinicians in Europe with an important new treatment option that has demonstrated rapid, sustained symptom relief.”
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, added: “The CHMP recommendation brings us closer to offering Tezspire to patients across the EU who face the daily challenges of this disruptive and difficult-to-treat disease.”
CRSwNP affects up to 320 million people globally. Nearly half of patients in Europe remain uncontrolled despite current therapies, which often rely on systemic corticosteroids and repeat surgeries.
Tezspire is already approved for severe asthma in the US, EU, Japan and over 60 countries. Regulatory reviews for CRSwNP are underway in the US, China, Japan and other markets.
