FDA Breakthrough Therapy Designation for AZ/Amgen’s tezepelumab

Tezepelumab is an antibody that targets thymic stromal lymphopoietin (TSLP) which Astra Zeneca believes could become the best possible treatment for severe asthma, which accounts for roughly 10% of all asthma patients. It works further up in the inflammatory cascade that causes asthma and therefore could be right for a larger number of patients than current treatments.
According to AZ, the FDA breakthrough therapy designation is for patients “without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.” The phase IIb PATHWAY study demonstrated a significant reduction in the annual asthma exacerbation rate versus placebo in a wide sample size of severe asthma patients. At mid-stage testing the current phase III PATHFINDER study is reducing several key asthma biomarkers including blood eosinophils, fractional exhaled nitric oxide (FENO) and immunoglobulin levels, and cutting asthma attacks, according to Pascal Soriot, AZ’s CEO.
AZ’s chief medical officer, Sean Bohen, said: “Tezepelumab is exciting because it has the potential to treat a broad population of severe asthma patients, including those ineligible for currently-approved biologic therapies. The BTD will help us bring tezepelumab to patients as quickly as possible.”