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Can GSK Market Breo Ellipta Dosing Advantage Without Adherence Advantage?

 
• By Sarah Karlin-Smith

After successful advisory panel – at least for adult asthma indication – Breo Ellipta seems headed for an expanded label, but GSK is still struggling to find some clinical differentiation from its aging twice-daily Advair.

GlaxoSmithKline PLC has been counting on Breo Ellipta to help it replace its aging warhorse Advair, but as the product appears to be headed for an expanded indication for asthma, it could face a bit of a marketing conundrum: Breo hasn’t been distinguished from Advair in clinical trials and it doesn’t have any adherence data that will make the once-daily advantage eligible for a potential clinical claim.

That could make for an uphill climb for Breo (fluticasone furoate/vilanterol), since the once-daily inhaled corticosteroid, long-acting beta agonist (ICS/LABA)...

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More from United States

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

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Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.