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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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.
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.
Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?