The U.S. Food and Drug Administration has approved Amgen (AMGN.O), opens new tab and AstraZeneca’s (AZN.L), opens new tab drug for a type of chronic inflammatory sinus disease, the drugmakers said on Friday.
The approval expands the use of the drug, Tezspire, as an add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps in adult and pediatric patients aged 12 years and older.
The condition causes the sinuses to stay inflamed for 12 weeks or more and soft, noncancerous growths called polyps to form in the nose. Symptoms include facial pain, reduced sense of smell and nasal congestion.
Tezspire is already approved as a single-use pre-filled syringe in the U.S., EU and other countries for add-on maintenance treatment for severe asthma.
The approval is based on the results from a late-stage study in which the drug showed clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
Tezspire also reduced the number of patients needing surgery for nasal polyps by 98% and reduced the need for oral steroids by 88%, the data showed.
Data for Tezspire shows that it might be more effective than Sanofi (SASY.PA), opens new tab and Regeneron’s (REGN.O), opens new tab Dupixent for patients with this condition, William Blair analyst Matt Phipps said ahead of the approval.
Tezspire, chemically known as tezepelumab-ekko, is a monoclonal antibody that blocks TSLP — a key protein involved in triggering and sustaining inflammation linked to severe asthma and related conditions.
The approval “shows the versatility of TSLP inhibition beyond asthma and highlights both companies’ commitment to take a really important scientific insight and way to treat patients into broad application that can make a real difference for patients,” said Kate Chevlen, global commercial head of inflammation portfolio at Amgen.
Other approved treatments for chronic rhinosinusitis include Dupixent, GSK’s (GSK.L), opens new tab Nucala as well as Roche (ROG.S), opens new tab and Novartis’ (NOVN.S), opens new tab Xolair.
