AstraZeneca, Amgen drug Tezspire wins US approval for chronic nasal condition
AstraZeneca and Amgen said Monday their drug Tezspire has been approved in the U.S. as a treatment for a chronic inflammatory nasal condition.
The Food and Drug Administration cleared the drug for adult and adolescent patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
According to the companies, Tezspire is the first biologic of its kind to be approved for the condition.
The approval was based on a late-stage trial where the drug significantly reduced the severity of nasal polyps and nearly eliminated the need for surgery compared to a placebo, the company said.
"Today's approval of Tezspire in chronic rhinosinusitis with nasal polyps expands the reach of this innovative treatment option to patients living with an epithelial-driven inflammatory disease beyond severe asthma," said Ruud Dobber, Executive Vice President of AstraZeneca's BioPharmaceuticals Business Unit.
The drug is already approved to treat severe asthma in more than 60 countries.
A European regulatory committee recently recommended the drug for approval for the same nasal condition, and applications are under review in several other countries.
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