"First-in-class" antibody therapy for a wide range of patients with severe asthma was approved by the FDA

A few days ago, Amgen (Amgen) and AstraZeneca (AstraZeneca) jointly announced that the "first-in-class" antibody therapy Tezspire (tezepelumab-ekko) has been approved by the US FDA as an additional maintenance therapy for the treatment of serious children and adults over 12 years of age.

Tezspire is a monoclonal antibody therapy targeting anti-thymic stromal lymphopoietin (TSLP)

▲TSLP affects the immune response of a variety of immune cells (picture source: reference [2])

This approval is based on a clinical development project called PATHFINDER, including the results of the pivotal Phase 3 clinical trial NAVIGATOR

The press release pointed out that tezepelumab is the first biological product to consistently and significantly reduce acute exacerbations of asthma in multiple phase 2 and phase 3 clinical trials for patients with severe asthma with a wide range of different characteristics

The main investigator of the NAVIGATOR trial, Professor Andrew Menzies-Gow of Royal Brompton Hospital, said that due to the complex and heterogeneous characteristics of severe asthma, although the development of new drugs has progressed, many patients still experience frequent acute exacerbations of the disease and severely reduce the quality of life.

Reference materials:

[1] TEZSPIRE (tezepelumab) Approved in the US for Severe Asthma.