Amgen, AstraZeneca report positive chronic rhinosinusitis results

Amgen and AstraZeneca jointly announced that their asthma medication, Tezspire, has proven effective in reducing nasal congestion and the size of nasal polyps in patients suffering from chronic rhinosinusitis with nasal polyps, a condition characterized by inflammation of the nasal lining. Tezspire, also known as tezepelumab, successfully met its co-primary endpoints in a Phase 3 clinical trial involving patients who had not responded to standard intranasal corticosteroid treatments. This condition often results in a loss of smell or facial pressure due to the inflammation.

The success of Tezspire positions Amgen and AstraZeneca to compete with several other biologics already approved for treating chronic rhinosinusitis with nasal polyps, such as Sanofi and Regeneron’s Dupixent, Genentech and Novartis’ Xolair, and GSK’s Nucala. Additionally, GSK recently reported positive data for its experimental antibody, depemokimab, adding to the competitive landscape. According to Andrew Menzies-Gow, the Vice President of respiratory and immunology at AstraZeneca, patients undergoing surgery or taking oral corticosteroids often experience significant side effects.

Although specific data from the Phase 3 trial has not yet been released, Amgen and AstraZeneca plan to present the full results to regulatory authorities and at an upcoming medical conference. The trial's promising outcomes suggest that Tezepelumab’s unique mechanism of action, which targets the top of the inflammatory cascade, sets it apart from other available treatments, as highlighted by Menzies-Gow.

Pablo Panella, AstraZeneca’s global head of respiratory and immunology, emphasized the importance of sharing the complete data for a more comprehensive understanding of how Tezspire stands against its competitors. Tezspire was initially approved in 2021 as a subcutaneous treatment for severe asthma and later received approval in 2023 for a self-administered formulation in a prefilled pen. For chronic rhinosinusitis with nasal polyps, AstraZeneca and Amgen intend to seek approval for both formulations, catering to preferences of some US patients who opt for clinic-based administration.

In 2023, Tezspire generated a combined revenue of $653 million for Amgen and AstraZeneca. The companies' next steps include presenting the full Phase 3 trial results to regulators and seeking approval for Tezspire’s use in treating chronic rhinosinusitis with nasal polyps, enhancing treatment options for patients with this inflammatory condition.