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Makena Hearing: Covis Seeks To Skip Question, Likely Negative Vote On Confirmatory Trial Results

 
• By Sue Sutter

By proposing to stipulate that findings from the PROLONG study do not verify Makena’s clinical benefit on neonatal morbidity and mortality from complications of preterm birth, Covis could avoid what would likely be a highly negative vote on the first question posed to the advisory committee at the 17-19 October public hearing on withdrawal of the application.

Fast forward
Covis wants to skip the first question on whether the PROLONG trial results verified Makena's clinical benefit. • Source: Shutterstock

Covis Pharma is requesting that a discussion and voting question related to the PROLONG confirmatory trial be eliminated from the October public hearing on potential withdrawal of Makena’s (hydroxyprogesterone caproate, or 17-0HPC) accelerated approval.

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More from US FDA Performance Tracker

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

 
• By Bridget Silverman

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.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 
• By Bridget Silverman

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

More from Regulatory Trackers

Global Pharma Guidance Tracker – February 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

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.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.