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.

lungs — FDA’s Antimicrobial Drugs Advisory committee will vote on Entasis’ antibiotic for two types of pneumonia 17 April. • Source: Shutterstock

Innoviva, Inc. subsidiary Entasis Therapeutics Holdings Inc. appears to be headed for an easy US Food and Drug Administration advisory panel for its combination antibacterial sulbactam-durlobactam (SUL-DUR) on 17 April, but it won’t be for the more lucrative pathogen-specific indication the company wanted.

The Antimicrobial Drugs Advisory Committee will vote on whether the overall benefit-risk assessment is favorable for use of SUL-DUR in...