AstraZeneca announced that the FDA has rejected its new drug application for a chronic obstructive pulmonary disease (COPD) therapy.
The treatment, Breztri Aerosphere, or PT010, is a triple combination inhaler that was approved in Japan this June.
AstraZeneca said it is working closely with the FDA to continue seeking approval and may submit data from a late-stage trial that was not completed when it originally submitted its application.
The company is hoping to catch up with GlaxoSmithKline, which already has a triple-combo COPD inhaler on the market that pulled in $147 million in sales in the second quarter.
Read the Reuters report.
