Medical Information

THOUSAND OAKS, Calif., Feb. 26, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from a pooled post-hoc analysis of the pivotal NAVIGATOR Phase 3 and PATHWAY Phase 2b trials showed TEZSPIRE™ (tezepelumab-ekko) demonstrated reductions in the annualized asthma exacerbation rate (AAER) across biomarker subgroups of patients with severe asthma.1 These findings support the role of TEZSPIRE as a first-in-class treatment for a broad population of people living with severe asthma, irrespective of biomarker levels.1

In the pooled analysis, TEZSPIRE, when added to standard of care (SoC), reduced asthma exacerbations in patients, irrespective of baseline blood eosinophil counts, demonstrating consistent efficacy with a 71% (≥300 cells per microliter), 48% (<300 cells per microliter) and 48% (<150 cells per microliter) reduction in the AAER over 52 weeks, compared to placebo added to SoC.1 In the same analysis, TEZSPIRE also demonstrated improvements in AAER in patients regardless of fractional exhaled nitric oxide (FeNO) level and allergy status over 52 weeks, compared to placebo.1

Additionally, in a pre-specified exploratory analysis from NAVIGATOR, TEZSPIRE demonstrated consistent efficacy throughout the year regardless of season.2 Data show that TEZSPIRE reduced the AAER by 63% (winter), 46% (spring), 62% (summer) and 54% (autumn) compared to placebo.2 The proportion of patients with an exacerbation was lower in the TEZSPIRE group than in the placebo group across all seasons.2

"The majority of severe asthma patients have multiple drivers of inflammation, triggered by allergens, viral and bacterial infections, and air pollution, all of which can contribute to ongoing exacerbations. These new results highlight TEZSPIRE's potential to reduce severe asthma exacerbations in patients irrespective of biomarker levels and seasonal triggers," said Dr. Jonathan Corren, clinical faculty member at the David Geffen School of Medicine, UCLA, and principal investigator of the PATHWAY trial.

"We're thrilled to continue seeing patients experience fewer asthma attacks following treatment with TEZSPIRE based on results from the latest analyses in the NAVIGATOR and PATHWAY trials," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These results further strengthen our belief that TEZSPIRE has the potential to be a transformative medicine for people living with severe asthma regardless of the season or their specific type of severe asthma."

These results are being presented at the 2022 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

TEZSPIRE is approved in the United States for the treatment of severe asthma and is under regulatory review in the EU, Japan and several other countries around the world.

Reference

https://www.amgen.com/newsroom/press-releases/2022/02/new-data-further-reinforce-efficacy-of-tezspire-tezepelumabekko-in-a-broad-population-of-severe-asthma-patients