GSK’s COPD Drug Gets A New Name (Breo) But May Face Familiar Challenges At FDA Panel
This article was originally published in The Pink Sheet Daily
The respiratory drug’s fate is uncertain given its mixed Phase III trial results; in two pivotal studies Breo, formerly Relovair, failed to demonstrate superiority to GSK’s Advair.
You may also be interested in...
GSK and Theravance released preliminary results of two Phase III studies for their COPD drug Relovair that could serve to help differentiate the drug from Advair.
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
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.