Trials set up filings for AZ's triple therapy in asthma
AstraZeneca's three-drug inhaler Breztri Aerosphere has shown efficacy for uncontrolled asthma in a pair of phase 3 trials that could extend its label beyond the drug's current use in chronic obstructive pulmonary disease (COPD).
In the KALOS and LOGO studies, Breztri (budesonide/glycopyrronium/formoterol fumarate) – known as Trixeo in some markets – achieved "a statistically significant and clinically meaningful improvement in lung function" compared to dual-drug therapies based on inhaled corticosteroids (ICS) and long-acting beta agonists (LABA), according to AZ.
Breztri layers in umeclidinium, a long-acting muscarinic antagonist (LAMA), to the ICS/LABA combination of budesonide and formoterol fumarate.
The company said it plans to submit the new data for regulatory review, and approval could add considerable momentum to Breztri, which is already knocking on the door of blockbuster status with sales up 44% to $978 million last year and with more than 5.5 million people worldwide prescribed the drug.
It was approved by the FDA as a treatment for COPD in 2020 and, according to GlobalData estimates, extending its label to include uncontrolled asthma could clear the way for sales to climb to more than $2.3 billion by 2030.
As many as 262 million people worldwide are affected by asthma, and it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life, said AZ in a statement.
Breztri is one of the medicines at the heart of AZ's growth aspirations in respiratory diseases along with IL-5 inhibitor Fasenra (benralizumab) and TSLP inhibitor Tezspire (tezepelumab), which are both approved for severe asthma indications and are also being developed for COPD. Last year, AZ also reported new data on Fasenra in acute asthma that it called the first major advance for this aspect of the disease in 50 years.
Respiratory is a key part of AZ's ambitious target of swelling group revenues to more than $80 billion in 2030 from a 2024 level of just over $54 billion. The company has high hopes for Breztri, suggesting it could generate $3 to $5 billion at its peak.
Full results from KALOS and LOGOS will be presented at an upcoming medical meeting.
"These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients," said AZ's head of biopharma R&D Sharon Barr.
Image by Hopestar21 from Pixabay
