Tezepelumab is a potential game changer for patients with non-TH2 or TH2-low asthma whose asthma is not well-controlled with inhaled corticosteroids, the current standard of care. Greenlighted by FDA in December and marketed under the brand name Tezspire, it is a first-in-class biologic for this patient population.
Tezepelumab targets the asthma inflammatory process earlier in the pathway than other treatments. It will likely be a first-line biologic for severe TH2-low asthma and a treatment option for TH2-high asthma patients who have failed existing therapies.
For patients with severe asthma without an eosinophilic phenotype:
BLA submitted to the FDA
Filing submitted in Japan
FDA granted priority review
Filing submitted in the EU
FDA authorized use as add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma
2022: United States
2023: Europe and Japan
Patents estimated to expire beginning in 2028
How will tezepelumab impact the market for asthma?
What gaps in treatment does tezepelumab fill?
Tezepelumab targets a subset of asthma patients who are underserved by available therapies and therefore have high unmet need, including patients with uncontrolled asthma with a non-TH2 /TH2-low phenotype who do not respond well to existing therapies. Dependence on oral corticosteroids for disease control is often not wholly effective and associated with long-term side effects. This is one of the most exciting emerging therapies for asthma treatment.
What hurdles might it need to overcome to reach blockbuster status?
Tezepelumab will face significant competition in TH2-high asthma patients, for whom it is expected to be used as later-line therapy given physician familiarity with existing biologics. With its later-to-market entry than other biologics for this patient population, payer restrictions could constrain uptake, similar to other high-priced biologics. For TH2-low asthma, there is no competition. For both phenotypes, the niche patient population with uncontrolled severe asthma could limit its overall patient share.
“I think the thing that’s most exciting is that it’s obviously for the type-2-low patient. Because there are limited options for that group of patients, I’m very excited about it.”
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021