FDA Greenlights AstraZeneca’s Fasenra for Rare Autoimmune Disease

AstraZeneca’s Fasenra, which accumulated $1.6 billion in sales last year, has received FDA approval to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. This marks Fasenra’s first new indication, placing it in direct competition with GSK’s Nucala, the only other approved treatment for EGPA.

Since their respective launches for severe asthma—Nucala in 2015 and Fasenra in 2017—both IL-5 inhibitors have dominated the market. Nucala initially gained an advantage with three additional indications over the years, but Fasenra’s approval for EGPA breaks new ground in this space. EGPA is a severe and potentially life-threatening condition, making this a significant development.

The approval was based on a phase 3 trial involving 140 patients, which showed closely matched remission rates at weeks 36 and 48—59% for Fasenra and 57% for Nucala. A key differentiator was steroid elimination: 41% of Fasenra patients were able to discontinue steroid use, compared to 26% for Nucala. This gives Fasenra a notable edge.

The FDA approval marks a turning point for AstraZeneca, positioning Fasenra as a strong competitor to Nucala in the EGPA market. With strong clinical trial results and participation in the first head-to-head biologic study, Fasenra’s new indication could drive significant changes in the treatment landscape for respiratory diseases.

For the latest updates and in-depth insights into the world of Pharmaceutical, including breakthrough treatments, industry trends, and regulatory news, contact Marcus Chalk today!