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The FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-akko) for severe asthma. But the drug may have limited uptake in the near term, according to one analyst.
FDA cleared Tezspire (tezepelumab-akko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma on December 17, but the near-term prospects of the drug are uncertain, partly becasue it has to be administered by a healthcare provider.
Tezspire is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label, Amgen said in a statement.
The first-in-class biologic for severe asthma acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.
"It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO)," Amgen said.
While the long-term outlook is more favorable, Geoffrey Porges, senior managing director, director of therapeutics research and a senior analyst with SVB Leerlink, has a negative short-term outlook on Tezspire.
“We believe Tezspire’s initial uptake is likely to be limited, although the long-term potential (assuming further trials and changes to the label) could be substantial,” Porges wrote.
The current label has several limitations that will initially hinder uptake, he noted. Importantly, the drug is limited to severe asthma patients, which is only 5 to 10% of asthma patients, compared to the label for dupilumab (Dupxient, Regeneron and Sanofi), which also covers moderate patients, Porges observed.
Moreover, the drug has to be administered by a healthcare provider in an office setting, compared to other biologics that can be administered at home. “We believe that Tezspire’s office administration requirement will initially limit its uptake in the current pandemic,” Porges said.
“While we believe Amgen will eventually update this label, in the short-term we believe this inconvenience will limit its uptake to only severe patients with low eosinophils where other biologics aren’t available or indicated (i.e., no other treatment options),” Porges said.
SVB Leerlink analysts expect Tezspire to be priced at around $22,000 per patient annually.
Tezspire’s approval was based on results from a Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy, Amgen said.
The approval “marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels," said David M. Reese, M.D., executive vice president of research and development at Amgen. "Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options."