- The FDA has declined to approve AstraZeneca Plc's (NASDAQ:AZN) asthma medicine, Fasenra (benralizumab), to treat chronic rhinosinusitis with nasal polyps, a condition characterized by benign growths that cause pain and stuffiness.
- The FDA has issued a complete response letter following AstraZeneca's application to extend the use of Fasenra and requested additional clinical data from it.
- Fasenra raked in $1.26 billion in sales in 2021, jumping 33% from the previous year.
- The application by AstraZeneca included data from the OSTRO Phase III trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine.
- The CRL requested additional clinical data, and the Company is working closely with the FDA regarding the next steps.
- The Company remains committed to bringing Fasenra to patients with chronic rhinosinusitis with nasal polyps, and a second Phase III trial, ORCHID, in this indication is ongoing.
- Price Action: AZN stock is up 1.82% at $61.40 during the market session on the last check Monday.
