Six years since the FDA blessed Sanofi and Regeneron’s Dupixent as the first biologic to treat chronic rhinosinusitis with nasal polyps (CRSwNP), a second biologic therapy has broken through with a nod in the indication.
The U.S. regulator has endorsed Amgen and AstraZeneca’s Tezspire as an add-on maintenance treatment for patients age 12 and older. The first-in-class monoclonal antibody, which is injected monthly, inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine which triggers inflammation.
It’s this novel mechanism of action that keys the effectiveness of Tezspire, which has produced clinical results that suggest it could become the top product on the market for CRSwNP.
“Tezspire is the only biologic that is able to target these cytokines upstream, next to the epithelium, and that gives you unique and broad coverage of that inflammation,” Pablo Panella, AstraZeneca’s senior vice president for global respiratory and immunology, said in an interview with Fierce Pharma.
This is the second indication for Tezspire, which was originally approved in 2021 as an add-on maintenance treatment for severe asthma. It has had a major impact on the asthma market, achieving sales of $1.2 billion in 2024 and on its way to a significant boost in 2025, with sales reaching $826 million in the first half of the year.
Although CRSwNP is not as prevalent a disorder as asthma, it still presents a substantial commercial opportunity because of the unmet need in the indication, according to Kate Tansey Chevlen, who heads up Amgen’s commercial efforts for its inflammation products.
“It’s mostly managed with intranasal steroids and surgery, so there’s really an opportunity to offer patients more and to provide more lasting relief,” Chevlen said. “We think there’s a significant market for biologics in this space because patients need more than what they’re getting today.”
Backing the label expansion were results from a phase 3 trial in which patients were treated for 52 weeks. The study achieved its two primary endpoints, showing significant improvements for Tezspire over placebo in total nasal polyp score (NCS) and nasal congestion score (NCS).
On NPS, a metric with a range of 0 to 8, treatment with Tezspire led to a placebo-adjusted average improvement of 2.08 points. On NCS, which is scored between 0 and 3, Tezspire performed 1.04 points better than placebo.
These figures compare favorably to those from a trial that facilitated Dupixent’s approval in the indication, with the usual caveat that cross-trial comparisons are often problematic because of design differences in the studies. Dupixent’s NPS improvement on placebo was an average of 1.8 points, and its difference versus placebo in NCS was 0.9.
Tezspire also fared better than GSK’s investigative oral treatment depemokimab, which recorded a 0.7 difference versus placebo in NPS. Depemokimab is lined up for an FDA decision in the indication in December of this year.
One key secondary endpoint from Tezspire’s trial was that it reduced the need for polyp surgery by 98%.
“It’s a near complete elimination of surgery, which is a very aggressive procedure for these patients. It’s extremely encouraging,” Panella said. “And we think the unique mechanism of action is responsible for that.”
CRSwNP affects roughly 320 million in the world, including 1 million to 2 million in the U.S. Of those, the companies believe there are roughly 300,000 patients who have need for a biologic treatment, but only about 40% of that group are currently taking them.