Tezspire (tezepelumab-ekko): First-in-Class Anti-TSLP Monoclonal Antibody Approved by FDA for Severe Asthma

Recently, Amgen and AstraZeneca jointly announced that the "first-in-class" antibody therapy Tezspire (tezepelumab-ekko) has been approved by the U.S. FDA as an add-on maintenance treatment for severe asthma in patients aged 12 years and older.

Tezspire is a monoclonal antibody therapy that targets thymic stromal lymphopoietin (TSLP). TSLP is an epithelial cytokine that sits at the top of multiple inflammatory cascades, initiating excessive immune responses associated with allergic, eosinophilic, and other types of airway inflammation linked to severe asthma. In September 2018, the U.S. FDA granted tezepelumab Breakthrough Therapy designation for the treatment of patients with severe asthma without an eosinophilic phenotype. Its biologics license application also received Priority Review status from the FDA.

▲TSLP affects immune responses in various immune cells (Image source: Reference [2])

This approval is based on the clinical development program named PATHFINDER, including the results of the pivotal Phase 3 clinical trial NAVIGATOR. The results of the NAVIGATOR trial were published in May 2021 in The New England Journal of Medicine. The trial results showed that, in treating patients with severe asthma whose symptoms were uncontrolled, tezepelumab achieved all primary endpoints and key secondary endpoints of the trial. Compared with placebo, it reduced the annualized asthma exacerbation rate (AAER) by 56% (p<0.001).

The press release noted that tezepelumab is the first biologic to consistently and significantly reduce asthma exacerbations across multiple Phase 2 and Phase 3 clinical trials in a broad population of severe asthma patients with different characteristics.

Andrew Menzies-Gow, Professor at Royal Brompton Hospital and principal investigator of the NAVIGATOR trial, stated that due to the complex and heterogeneous nature of severe asthma, many patients continue to experience frequent disease exacerbations despite advancements in new drug development, significantly reducing their quality of life and increasing hospitalization risks. Tezspire offers a much-needed new treatment option for severe patients unable to control their symptoms.

References:

[1] TEZSPIRE (tezepelumab) Approved in the US for Severe Asthma. Retrieved December 18, 2021, from https://www.businesswire.com/news/home/20211217005407/en

[2] Comeau & Ziegler. (2009). The influence of TSLP on the allergic response. Mucosal Immunology, https://doi.org/10.1038/mi.2009.134

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