FDA Declines To Approve AstraZeneca's Asthma Treatment For Chronic Nasal Condition - AstraZeneca (NASDAQ:AZN), AstraZeneca (OTC:AZNCF)

The FDA has declined to approve AstraZeneca Plc's 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.