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Reopening The LABA Class: FDA Shepherds Breo Through Committee For Asthma

 
• By Jacqueline Fitton and Michael McCaughan

A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive. In this case, FDA seems more concerned that too much emphasis on safety is steering development aware from an area of significant medical need.

The March 19 FDA advisory committee review of GlaxoSmithKline PLC’s Breo Ellipta (fluticasone furoate and vilanterol) combination product to treat asthma shows just how far FDA has moved from out of the shadow of safety scares that dominated the regulatory climate a decade ago.

When the joint meeting of the Pulmonary-Allergy Drugs and Drug Safety & Risk Management Advisory Committees was announced,

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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
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In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
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More from Product Reviews

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.