08:56 AM EDT, 04/11/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Thursday that the US Food and Drug Administration has approved Fasenra as an add-on maintenance treatment for children aged 6 to 11 having severe asthma with an eosinophilic phenotype.

The regulator's decision was based on a late-stage trial that evaluated the safety of Fasenra in 28 patients in the US and Japan aged 6 to 11 suffering from severe eosinophilic asthma, AstraZeneca ( AZN ) said. The trial showed that the safety and tolerability of Fasenra were "consistent" with the medicine's known profile, the company said.

Fasenra was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in patients 12 years and older, AstraZeneca ( AZN ) said.

Shares of AstraZeneca ( AZN ) were up 2.6% in recent Thursday premarket activity.

Price: 69.85, Change: +1.74, Percent Change: +2.55