Can Viatris’ Revived Revatio Bid In Pediatric PAH Overcome Past Obstacles To US FDA Approval?
Behind FDA’s decision to call, and then to call off, an advisory committee for pediatric use of Viatris’ Revatio (sildenafil) in pulmonary arterial hypertension lies a debate going back more than a decade, review documents show.
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Zejula, Revatio Advisory Committee Meetings Cancelled; Palovarotene Panel Postponed
Panel to review overall survival data on GSK’s Zejula for ovarian cancer ‘is no longer needed,’ US FDA says. Meeting to consider pediatric indication for Viatris’ Revatio was also cancelled though sNDA remains active. FDA to review new information on Ipsen’s palovarotene clinical trial data.
Pediatric Data Planning Should Start While Adult Drug Development Is In Its Infancy
Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.
Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker