BRIEF—AstraZeneca receives new FDA approval of Fasenra

UK pharma major AstraZeneca today revealed that Fasenra (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged six to 11 with an eosinophilic phenotype.

Fasenra was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged 12 and older.

The additional indication for Fasenra was supported by evidence from TATE, an open-label, multinational, non-randomized, parallel assignment Phase III trial, as well as adequate and well-controlled trials in adult and adolescent populations.

In the TATE study, Fasenra met the primary endpoints, demonstrating pharmacokinetics (PK) and pharmacodynamics (PD) in children aged six to 11 years old with SEA were consistent with those seen in prior trials.

The safety and tolerability of Fasenra in the trial was also consistent with the known profile of the medicine.