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

14 Oct 2022

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.

Apple — 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,...