Astrazeneca's Tezspire secures EU approval

(Sharecast News) - Drugmaker AstraZeneca said on Wednesday that its chronic rhinosinusitis with nasal polyps treatment, Tezspire, has been approved in the European Union as an add-on therapy with intranasal corticosteroids for adults. AstraZeneca said the European Commision's approval of Tezspire, developed in conjunction with Amgen, follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from the WAYPOINT Phase III trial.

In the trial, Tezspire demonstrated a "statistically significant and clinically meaningful reduction" in nasal polyp severity, and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use versus placebo.

Ruud Dobber, president of AstraZeneca's BioPharmaceuticals Business Unit, said: "In Europe, we know that nearly half of patients with chronic rhinosinusitis with nasal polyps remain uncontrolled despite treatment with standard of care, which is why today's approval of Tezspire is such an important step forward in this challenging disease.

"This approval broadens Tezspire's benefits beyond severe asthma and reinforces Tezspire's innovative mechanism of action that targets thymic stromal lymphopoietin, uniquely addressing epithelial-driven inflammation at its source."

As of 0810 BST, AstraZeneca shares were down 0.72% at 12,474p.





Reporting by Iain Gilbert at Sharecast.com