After reviewing results from trials involving more than 41,000 asthma patients, the FDA has agreed to remove the boxed warning of serious asthma-related outcomes for AstraZeneca‘s (NYSE:AZN) Symbicort product.
Patients using Symbicort, which combines an inhaled corticosteroid and a long-acting beta2-adrenergic agonist in a single inhaler, did not experience a significant increase in the risk of a serious asthma-related event, according to data from four clinical trials.
The data also showed that the combination medicine more effectively lowered asthma attacks than an inhaled corticosteroid alone. The FDA has agreed to add that data to the ICS/LABA labels, AstraZeneca reported.
“This new labeling provides clinically relevant information on the safety profile of ICS/LABAs including Symbicort as a treatment option for people living with asthma, one of the most common chronic respiratory diseases,” Chris Blango, VP of U.S. medical affairs for AstraZeneca’s respiratory business, said in prepared remarks.
“This year, Symbicort received two other label updates, in addition to this latest safety data update, which underscores AstraZeneca’s commitment to continually validate the well-established safety profile of Symbicort and the importance of ICS/LABA combination therapy.”
AZN shares were trading at $33.38 apiece in mid-afternoon activity today, up 1%.