Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate

AstraZeneca's inhaler Breztri Aerosphere, which was approved for COPD in 2020, has taken a step toward a label expansion as it has aced two asthma trials. AstraZeneca has taken a key step in advancing Breztri Aerosphere toward a potential label expansion and achieving its goal of annual sales of $3 billion to $5 billion for the 3-in-1 inhaler.Two phase 3 trials evaluating the effectiveness and safety of Breztri in a total of 4,434 patients with uncontrolled asthma have met their primary endpoints. The studies showed that Breztri delivered statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments, AZ said.Data from the KALOS and LOGOS studies will be shared with regulatory authorities and presented at an upcoming medical meeting, the company added.Breztri Aerosphere, which was approved for chronic obstructive pulmonary disorder (COPD) in 2020, is a fixed-dose combination of the corticosteroid budesonide, the LABA formoterol fumarate and the long-acting muscarinic antagonist (LAMA) glycopyrronium.With sales (PDF) of $300 million in the first quarter of 2025, an increase of 37% year over year, Breztri is on its way to blockbuster status for the first time this year.A label expansion to treat asthma would open the treatment up to another large patient population. The condition affects roughly 262 million people around the world, AZ said, with nearly half of those treated with dual therapies remaining uncontrolled. “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing,” Alberto Papi, of the St. Anna University Hospital in Ferrara, Italy, said in a press release. “The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of Breztri to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy.”Breztri was developed as a combination of AZ’s blockbuster Symbicort (budesonide/formoterol), which was approved for asthma in 2006, and Bevespi (formoterol fumarate/glycopyrrolate), which was approved for COPD in 2016. In its development, Breztri has trailed GSK’s triple therapy Trelegy Ellipta, which was approved for COPD in 2017 and for asthma in 2020. Trelegy generated sales of $3.5 billion in 2024, an increase of 26%. GlobalData forecasts that sales of Breztri will reach $2.3 billion in 2030.Breztri is one of several treatments AZ is developing for respiratory diseases, including Fasenra and Amgen-partnered Tezspire. Both of those drugs have been approved to treat asthma and AZ is eying potential COPD label expansions. Fasenra achieved sales of $1.7 billion last year. AZ reported sales for fast-rising Tezspire, which was approved in 2021, at $684 million.

Having recently been selected for the second round of US drug price talks, GSK's chronic obstructive pulmonary disease (COPD) treatments Trelegy Ellipta and Breo Ellipta have received a boost from the Institute for Clinical and Economic Review (ICER) ahead of the start of negotiations.An analysis from the cost watchdog determined that GSK's two inhaled therapies "offer the advantage of requiring only one puff once a day" for the maintenance treatment of COPD. In contrast, comparator generics to Trelegy Ellipta require two inhalers administered twice daily, while for Breo Ellipta, they generally require at least one inhaler twice daily. According to ICER, observational data suggest that patients are more adherent to once-daily therapy, which may lead to fewer COPD exacerbations. The watchdog concluded that Trelegy Ellipta has comparable or incremental net health benefits compared with other generic triple therapies, with the same for Breo Ellipta versus generic inhaled corticosteroid/long-acting beta-agonist dual therapies administered twice daily.Breo Ellipta combines the inhaled corticosteroid fluticasone furoate with the long-acting beta-agonist vilanterol, while Trelegy Ellipta adds the long-acting muscarinic antagonist umeclidinium to this dual regimen. A recent analysis indicated that total Part D Medicare prescription drug costs for Trelegy Ellipta between November 1, 2023, and October 31, 2024, were $5.1 billion, and $1.4 billion for Breo Ellipta.ICER chief executive Sarah Emond noted that the new analysis "will be one of many inputs" considered by the Centers for Medicare & Medicaid Services in negotiations with GSK. "We hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people."