FDA hits back Fasenra in key rhinosinusitis field, putting AstraZeneca even further behind Big Pharma rivals
AstraZeneca will have to sit outside the ring of a hotly contested respiratory fight for now.
Despite what the pharma giant described as positive Phase III data, the FDA has rejected its sBLA for Fasenra in patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The complete response letter “requested additional clinical data,” according to AstraZeneca.
Fasenra, an IL-5 inhibitor first approved in late 2017 as an add-on maintenance treatment to treat a severe form of asthma, was already playing catch-up to Sanofi/Regeneron’s Dupixent, GlaxoSmithKline’s Nucala and Novartis’ Xolair in CRSwNP. While Nucala, like Fasenra, blocks IL-5, Dupixent inhibits IL-4 and IL-13 while Xolair targets IgE.
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