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Breo Inverts Traditional Path To COPD Indication For LABA Combinations

 
• By Cathy Dombrowski

GlaxoSmithKline’s NDA for Breo Ellipta sought a COPD indication without prior approval of the combination product or its individual inhaled corticosteroid and long-acting beta agonist components in asthma. A broad development program with extensive dose finding won over a skeptical FDA.

A robust clinical development program allowed GlaxoSmithKline PLC to break with precedent and gain a chronic obstructive pulmonary disease indication for Breo Ellipta, a combination of an inhaled corticosteroid and long-acting beta agonist, without first obtaining FDA approval for the individual components and the combination to treat asthma.

The path of LABA and ICS/LABA products to a COPD indication historically has started with asthma because asthmatics have greater airway sensitivity to LABA adrenergic activation and their reaction to...

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More from United States

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• By Cathy Kelly

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

More from North America

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.