A few months after a key label expansion, AstraZeneca’s asthma treatment Fasenra has received FDA approval to treat a rare inflammatory disease.
The company said Wednesday that the biologic has been approved by US regulators to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare form of blood vessel inflammation that affects about 50,000 people in the US. It’s another notch on Fasenra’s belt as it looks to catch up to GSK’s Nucala.
The new indication was based on a head-to-head Phase 3 study testing a once-monthly subcutaneous dose of Fasenra against three injections of Nucala every four weeks. AstraZeneca touted that 41% of patients given Fasenra were able to taper off steroids compared to 26% in the Nucala arm. There was a 59% adjusted remission rate for patients given Fasenra versus 56% for Nucala, a difference that was non-inferior but not superior.
AstraZeneca has been working to keep pace with its UK rival in treating severe asthma and now continues the commercial jostling in EGPA. Fasenra had its label expanded in April to treat 6 to 11-year-old patients with severe asthma, a population that Nucala received approval for back in 2019. In March, AstraZeneca launched a new marketing campaign for the therapy.
Fasenra has been AstraZeneca’s second-best selling drug in its respiratory and immunology division, totaling $781 million in revenue through the first half of the year, a 3% increase compared to the first half of 2023.
Nucala, meanwhile, earned £856 million ($1.14 billion) in the first half of 2024, an 11% increase from 2023.