Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Can Viatris’ Revived Revatio Bid In Pediatric PAH Overcome Past Obstacles To US FDA Approval?

Executive Summary

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.

You may also be interested in...



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.

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?

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS147258

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel