Keeping Track: Entasis’ Antibiotic Xacduro, Two Opioid Misuse Therapies Clear US FDA; Pfizer’s Paxlovid Makes It Official
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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FDA Advisors Give Entasis Antibiotic Unanimous Thumbs Up, But Call For Strong Postmarket Surveillance
High unmet need and a potentially more favorable safety profile than current options got sulbactam-durlobactam a favorable advisory panel.
Entasis Antibiotic Indication Changed Ahead Of FDA Panel, Ending Quest For First Pathogen-Specific Approval
Entasis’s sulbactam-durlobactam gets solid review from FDA ahead of its 17 April advisory committee meeting, but the company looks like it will have to settle for a narrower indication than it initially proposed.
Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.