AstraZeneca Korea is soon to test the efficacy and safety of tezepelumab, an asthma treatment, on local patients.
The Ministry of Food and Drug Safety on Tuesday approved the company’s plan for a phase 3 clinical trial on tezepelumab.
The clinical trial will test the efficacy and safety of the drug for 100 adults and adolescents with severe, uncontrolled asthma. Under the study name of NAVIGATOR, the trial will be multicenter, randomized, double-blind, placebo-controlled, parallel group, and phase 3.
The study will be carried out at 14 institutions, including the Seoul National University Hospital, Samsung Medical Center, Seoul Medical Center, and Severance Hospital.
AstraZeneca and Amgen are co-developing tezepelumab, an injection beneath the skin.
According to a phase 2b clinical trial, PATHWAY, announced in the New England Journal of Medicine in September, asthma patients on tezepelumab had a significant reduction in asthma exacerbation, compared with a placebo group.
During the study, researchers administered the investigational drug to patients with uncontrolled asthma whose symptoms exacerbated despite the use of long-acting beta-2 agonists.
The asthma exacerbation rates of the patients on tezepelumab at a dose of 70 mg or 210 mg every four weeks, or 280 mg every two weeks, went down by 61 percent, 71 percent, and 66 percent, respectively. Such results were an achievement of the primary endpoint.
Tezepelumab’s incidence of adverse effects was similar to that of placebos. Most common adverse effects include asthma, nasopharyngitis, headache, and bronchitis.
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