AstraZeneca has received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for benralizumab for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
The sBLA includes data from the phase 3 OSTRO study (ClinicalTrials.gov Identifier: NCT03401229), which showed that treatment with subcutaneously administered benralizumab led to statistically significant improvements over placebo in patients with severe nasal polyposis (regardless of blood eosinophil count) who were symptomatic despite standard of care therapy. Efficacy was measured by change from baseline in the endoscopic total nasal polyp score and mean nasal blockage score at week 40.
According to the letter, additional clinical data would be required for the Agency to complete its review and make a final decision on the new indication. Benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, is marketed under the brand name Fasenra® for severe eosinophilic asthma.
A second phase 3 trial, ORCHID (ClinicalTrials.gov Identifier: NCT04157335), is currently investigating benralizumab vs placebo in patients with eosinophilic CRSwNP. The 56-week study will measure both nasal polyp burden and patient-reported nasal blockage. Trial results are expected in the second half of 2023.
In a press statement, the Company said it was working closely with the FDA on next steps.
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps. News release. March 14, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/update-on-us-review-of-fasenra-in-nasal-polyps.html