FDA Panel Will Weigh Mixed Efficacy Data For GSK’s Breo Ellipta In COPD
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency says data supporting the relative contribution of the combination drug’s corticosteroid component, fluticasone, are “less robust” than data supporting the bronchodilatory effects of the long-acting beta-agonist component, vilanterol.
You may also be interested in...
Relovair Data Raises Respiratory Stakes For GSK And Theravance
Mixed Phase III data results on GSK/Theravance’s once-daily follow-up to Advair raises the regulatory and commercial stakes for the drug, a crucial pipeline product for both companies
Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.
Two Years In US Accelerated Approval Withdrawals
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.