UNITED KINGDOM – AstraZeneca (AZ) announced that the US Food and Drug Administration has declined to approve Fasenra, its asthma medication, for the treatment of chronic rhinosinusitis with nasal polyps, a condition characterized by benign growths that cause pain and stuffiness.
According to AZ, the US regulator has requested additional clinical data, but the company remains committed to bringing the drug to patients with the inflammatory condition, which results in the growth of nasal polyps in the nose, which can sometimes necessitate surgical intervention.
Fasenra (benralizumab) from AZ hopes to join rival drugs from Sanofi/Regeneron and GlaxoSmithKline as approved therapies for chronic rhinosinusitis with nasal polyps (CRSwNP) that have been shown to reduce symptoms.
The London-listed pharmaceutical company said the U.S. Food and Drug Administration (FDA) issued a complete response letter in response to AstraZeneca’s application to extend the treatment’s use and requested additional clinical data from it.
Fasenra was AstraZeneca’s first respiratory biologic, with sales of US$1.26 billion in 2021, up 33% from the previous year.
It belongs to a class of medications known as monoclonal antibodies, and it is used to treat severe asthma.
From the same drug class, the treatment competes with GlaxoSmithKline’s Nucala and Teva’s Cinqair, while AstraZeneca has also developed a newer medicine, Tezspire, with Amgen, which would compete with Fasenra.
An approval would have put Sanofi’s Dupixent and Novartis’ Xolair, the two biologic respiratory drugs approved to treat chronic rhinosinusitis with nasal polyposis to the test.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma, with sales of US$1.3 billion in 2017.
It is also being developed for other indications, including hypereosinophilic syndrome (HES) and eosinophilic oesophagitis, with phase 3 readouts expected later this year in both cases.
Standard treatments for CRSwNP after surgery include corticosteroids in the nose, and systemic corticosteroids, but they are often ineffective.
It is fairly common – approximately 2% of people in the United States have chronic rhinosinusitis, and 25% to 30% develop nasal polyps as a result.
The setback for AstraZeneca’s Fasenra comes after the drugmaker announced that the FDA had approved Lynparza, a cancer drug co-developed by AstraZeneca and Merck, as a treatment for patients with early-stage breast cancer with certain mutations.
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