Amgen is asking the FDA to greenlight a potential first-in-class biologic to treat severe asthma.
The treatment, tezepelumab, is a thymic stromal lymphopoietin targeting antibody that was developed to halt the inflammatory cascade that triggers asthma. The company says there are over 2.5 million patients globally with severe asthma that is not being properly controlled with current therapies.
In a phase 3 trial, patients on tezepelumab experienced a 56% reduction in asthma attacks compared the current standard of care, which is typically inhaled corticosteroids along with another controller drug.
If given the go-ahead, the drug will face competition from Sanofi and Regeneron’s Dupixent, a best-selling therapy targeting several allergic diseases such as eczema and asthma.
But Amgen, who developed the drug with AstraZeneca, says that tezepelumab is the only biologic that has been shown in phase 2 and 3 trials to consistently and significantly reduce annualized asthma exacerbation rate in a broad population of patients.
Tezepelumab was granted a Breakthrough Therapy Designation from the FDA in 2018.
The companies are now hoping for an approval decision by early 2022.
