Amgen, AZ's Tezspire challenges Dupixent in nasal polyps

Amgen and AstraZeneca's Tezspire has claimed FDA approval as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP), its second indication after severe asthma.

The anti-TSLP antibody has been cleared by the US regulator as an add-on maintenance treatment for patients aged 12 and older with CRSwNP, a chronic form of inflammatory sinus disease.

That makes Tezspire (tezepelumab) the first direct competitor to Sanofi and Regeneron's IL-4 and IL-13 inhibitor Dupixent (dupilumab), which became the first approved therapy for CRSwNP, getting the go-ahead for use in adults whose CRSwNP symptoms are uncontrolled despite treatments such as systemic steroids and surgery. Last year, Dupixent's label was extended to include the 12 to 17 age group.

Other biologics have reached the market for CRSwNP, including GSK's IL-5 inhibitor Nucala (mepolizumab) and Roche's anti-IgE antibody Xolair (omalizumab), although both of those can be used as add-on maintenance therapy only in adults with inadequate response to nasal corticosteroids.

Tezspire has been available since 2021 in the US as a treatment for adult and paediatric patients aged 12 years and older with severe asthma, which is less common than CRSwNP, although the two diseases are linked as nasal polyps often occur in severe asthma cases.

The new indication adds a major growth driver for Tezspire, which has already entered into blockbuster sales territory with AZ and Amgen reporting combined turnover of more than $1.2 billion for the drug last year, almost twice what it made in 2023, and added another $826 million in the first half of this year.

It is estimated that there are around 320 million people living with CRSwNP around the world, not far off the number with asthma and many times more than those with severe asthma, so there is considerable potential for further growth for Tezspire if it makes headway in CRSwNP.

"For people living with CRSwNP, every breath can feel like a struggle, and many endure years of recurring symptoms and surgeries without significant relief," said Jay Bradner, Amgen's R&D chief, who noted that Tezspire works higher up the inflammatory cascade than rival therapies.

"The approval of Tezspire represents a meaningful advance, derived from our longstanding focus on complex inflammatory diseases rooted in epithelial biology," he added.

Also in the new product's favour is once-monthly subcutaneous administration, whereas Dupixent needs an injection every two weeks.

The approval is based on the results of the WAYPOINT phase 3 trial, in which Tezspire showed a statistically significant reduction in nasal polyp severity and achieved near-elimination of the need for surgery, as well as a significant reduction in systemic corticosteroid use, compared to placebo.

Another major opportunity for Tezspire could be on the way for Amgen and AZ after the drug showed promise as a treatment for chronic obstructive pulmonary disease (COPD) – another indication with hundreds of millions of patients worldwide – in a mid-stage trial reported last year.