FLAME study shows superiority of Novartis' Ultibro Breezhaler over Seretide in reducing COPD exacerbations
First large-scale study to confirm Ultibro Breezhaler is an effective steroid-free option that both reduces exacerbations and improves lung function in COPD patients with one or more exacerbations in the past year, compared to Seretide.
Novartis has announced positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.
This finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.
"Today's FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients."
Related News
-
News Understanding the Benefits and Advances of Cleanroom Technology
In an industry where precision and sterility are crucial concerns, cleanrooms play a vital role in maintaining the integrity of pharmaceutical products like drugs, vaccines, and other medical products. So, what is a cleanroom?
-
News AbbVie secures GBP£1.2 billion deal for Gilgamesh’s psychedelic programme
AbbVie has penned a significant agreement to acquire the bretisilocin programme from Gilgamesh Pharmaceuticals for up to £1.2 billion, marking a bold step in the pharmaceutical giant's quest to develop treatments for psychiatric disorders. -
News Gates Foundation commits US$2.5 billion to women’s health research
The Bill & Melinda Gates Foundation has announced a substantial US$2.5 billion commitment to accelerate research and development focused exclusively on women's health through 2030.
-
News Mid-year review: notable FDA drug approvals of 2025
As we fly past the halfway point of 2025, the pharmaceutical landscape reliably continues to evolve with innovative therapies addressing critical medical needs. The FDA has already approved 17 groundbreaking medications this year, each representin... -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience.