The FDA issued a complete response letter, so AstraZeneca’s monoclonal antibody won’t be joining Nucala and Dupixent as treatments for chronic rhinosinusitis with nasal polyps anytime soon.
AstraZeneca announced today that the FDA has not accepted its application to have Fasenra (benralizumab), a monoclonal antibody already approved for asthma, be additionally approval as a treatment for chronic rhinosinusitis with nasal polyps.
But the company said in a news release that it was committed to moving ahead with Fasenra as a treatment for chronic rhinosinusitis with nasal polyps and that a second phase 3 trial, dubbed ORCHID, is underway.
AstraZeneca used results from a prior phase 3 trial, called OSTRO, in the application that led to the FDA issuing a complete response letter.
The FDA issues a complete response letter when it finds shortcomings in a drug developer’s application. The shortcomings can range from minor problems that are easily remedied or major ones that require a new clinical trial or signal a serious problem with the drug. AstraZeneca’s news release didn’t have any details on the reason for the FDA’s complete response letter.
The competition among monoclonal antibody to be used as treatments for chronic rhinosinusitis with nasal polyps is heating up, and the spin on the news about the FDA complete response letter was that Fasenra was falling behind. The FDA approved GlaxoSmithKline’s Nucala (mepolizumab) as a treatment in July 2021 and Sanofi and Regeneron’s Dupixent (dupilumab) in June 2019.
“AstraZeneca’s Fasenra is already late to the game in nasal polyps, and now the drug is being pushed back even further — if it can eventually get there,” reported Fierce Pharma.