Tezepelumab wins breakthrough designation for eosinophilic COPD
FDA decision based on positive findings from COURSE clinical trial
The U.S. Food and Drug Administration (FDA) has granted breakthrough designation to tezepelumab, an approved therapy for severe asthma, as an add-on maintenance treatment for moderate to very severe chronic obstructive pulmonary disease (COPD) marked by an eosinophilic profile.
An eosinophilic profile refers to high blood levels of eosinophils, a type of immune cell. Abnormally high eosinophil counts have been linked to type 2 inflammation, which may contribute to lung inflammation in COPD and asthma.
The designation was announced in a press release by Amgen, which is developing tezepelumab with AstraZeneca.
The FDA’s breakthrough therapy designation is designed to help accelerate the development of experimental treatments that have the potential to substantially improve care for serious diseases by providing certain incentives, such as more frequent communication and advice from the agency during the drug development process, along with possible eligibility for priority review, which shortens the approval review process from 10 to six months.
What is tezepelumab?
Tezepelumab is an antibody-based therapy approved in the U.S. and the European Union under the name Tezspire as an add-on treatment for severe asthma in patients aged 12 and older. It’s designed to reduce airway inflammation, which plays a central role in COPD and asthma, by blocking the activity of thymic stromal lymphopoietin (TSLP), an inflammatory protein released by airway cells in response to smoke, viruses, and other insults, and is involved in eosinophil-related and other types of airway inflammation. Releasing TSLP into the airways may contribute to severe COPD exacerbations, that is, when lung symptoms get suddenly worse.
The breakthrough designation was based on positive findings from COURSE (NCT04039113), a proof-of-concept Phase 2 clinical trial that enrolled more than 330 adults with moderate to very severe COPD.
Its participants were randomly assigned to receive injections under the skin of either 420 mg of tezepelumab or a placebo once a month for about a year.
The results, which were presented this year, indicated tezepelumab reduced rates of COPD exacerbations by 17% relative to a placebo. While the differences failed to reach statistical significance in the overall patient population, they were statistically significant among patients with intermediately high eosinophilic counts. In this subgroup, as well as those with very high eosinophilic counts, tezepelumab was associated with better lung function and health-related quality of life over a placebo.
The therapy’s safety profile in these COPD patients was consistent with the known safety profile of tezepelumab in severe asthma patients.
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