No USFDA approval for AstraZeneca's treatment for chronic nasal condition
The London-listed drugmaker said the U.S. Food and Drug Administration (FDA) had issued a complete response letter following AstraZeneca's application to extend use of the treatment and requested additional clinical data from it.;
New Delhi: - AstraZeneca Plc said on Monday the U.S. drug regulator declined to approve its asthma medicine, Fasenra, for treatment of chronic rhinosinusitis with nasal polyps, a condition characterised by benign growths that cause pain and stuffiness.
The London-listed drugmaker said the U.S. Food and Drug Administration (FDA) had issued a complete response letter following AstraZeneca's application to extend use of the treatment and requested additional clinical data from it.
Fasenra was AstraZeneca's first respiratory biologic and raked in $1.26 billion in sales in 2021, jumping 33% from the previous year. It belongs to a class of medicines called monoclonal antibodies and is used against severe asthma.
The treatment rivals GlaxoSmithKline's Nucala and Teva's Cinqair from the same drug class, while AstraZeneca has also developed a newer medicine, Tezspire, with Amgen (AMGN.O) which would compete with Fasenra.
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