AMR-Targeting Drug Secures EMA PRIME Designation

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.

Antimicrobial Resistance and bacteria changing over time and no longer responding to medicines
MEM-ANT3310 is a next-generation, broad-spectrum antibacterial (Shutterstock)
Key Takeaways
  • MEM-ANT3310 and radiprodil, from Antabio and GRIN Therapeutics respectively, are the latest investigational products to make it onto the European Medicines priority medicines (PRIME) scheme.
  • MEM-ANT3310 addresses antimicrobial resistance in severe hospital infections, while radiprodil targets GRIN-related neurodevelopmental disorder, a condition for which there are currently no approved therapies.
  • PRIME enables the EMA to offer companies early and enhanced support that can help them optimize their development plans.
  • The Pink Sheet’s PRIME tracker provides the status of all 148 products that have been accepted onto the scheme to date.

MEM-ANT3310, which Antabio is developing to address antimicrobial resistance (AMR) in severe hospital infections, is among the latest products to secure a place on PRIME, the European Medicines Agency’s priority...

The next-generation, broad-spectrum antibacterial is for treating infections due to aerobic Gram-negative organisms in adults with limited treatment options. It has been designed to make a significant impact on the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Review Pathways

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By 

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

More from R&D

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.