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Cempra’s Antibiotic Likely Needs Bigger Trial – But Might Be Able To Do It In Phase IV

 
• By Michael Cipriano

FDA advisory committee votes 7-6 that the strong efficacy profile of Solithera (solithromycin) outweighs its unknown safety risks; panels agreed that more data was needed, but were split on whether it was needed pre- or post-approval.

Cempra Inc.'s community acquired bacterial pneumonia (CABP) antibiotic Solithera (solithromycin) barely squeaked passed an FDA advisory panel, but the drug will likely be forced to conduct another clinical trial of the drug regardless of the approval outcome.

The Antimicrobial Drugs Advisory Committee voted 7-6 that the efficacy results of Solithera outweigh its risks, including hepatotoxicity

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

Global Pharma Guidance Tracker - March 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.