Amgen, AstraZeneca's asthma drug nabs speedy FDA review

Amgen and AstraZeneca's asthma drug tezepelumab has moved up in the FDA's queue after receiving a priority review that sets a decision date into the first quarter of 2022. 

The companies, who teamed up to develop tezepelumab in 2012, presented mixed data on the molecule late last year. One phase 3 linked the drug to statistically significant reductions in exacerbations in asthma patients, only for a second late-phase study to find it was unable to cut daily oral corticosteroid dosing without loss of asthma control.

Amgen and AstraZeneca are betting that the drop in exacerbations, coupled with the lack of clinically meaningful differences in the safety results between the tezepelumab and placebo groups, will be enough to get the drug over the line at the FDA. 

Researchers shared full data from the successful phase 3 trial in May. An analysis showed a 77% reduction in asthma exacerbations for certain patients with key biomarkers called eosinophils and fractional exhaled nitric oxide. These are linked to inflammation in the lungs and the severity of asthma, respectively. 

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The analysis also found an 85% reduction in exacerbations that required hospitalizations for patients with severe, uncontrolled asthma.

The performance of tezepelumab in patients with low levels of eosinophils could be critical to the competitive positioning of the monoclonal antibody. While drugs such as Regeneron and Sanofi’s Dupixent and AstraZeneca’s Fasenra have improved the lives of people with eosinophilic asthma, up to 50% of patients with non-eosinophilic disease have limited effective treatment options.

Tezepelumab could address the unmet need by hitting a target further upstream in the inflammatory cascade than existing therapies. The 2012 agreement put AstraZeneca in charge of development and commercialization of tezepelumab. Amgen will keep a mid-single-digit royalty, after which profits will be split equally.

The therapy was previously granted a breakthrough therapy designation in September 2018.