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Makena Randomized, Controlled Trial Proposal Shows Evolution In Covis’ Thinking

 
• By Sue Sutter

Just three years ago, then-sponsor AMAG Pharmaceuticals said another trial of the preterm birth prevention drug in the US would be unethical and infeasible. Now, AMAG parent Covis is proposing to conduct a new study designed to address the shortcomings of the PROLONG trial.

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Covis is seeking another bite at the confirmatory trial apple to try to prove Makena's clinical benefit. • Source: Shutterstock

Covis Pharma is hoping to convince a US Food and Drug Administration advisory committee – and senior agency officials – that its preterm birth prevention drug Makena (hydroxyprogesterone caproate injection, also known as 17-OHPC or 17P) should stay on the market while it conducts a new US randomized, controlled trial designed to address the shortcomings of the PROLONG study.

The current study proposal is yet another milestone in the evolution of the product sponsor’s thinking about the need for, and feasibility of, conducting a new confirmatory trial for the...

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More from Post-Marketing Regulation & Studies

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

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.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.