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Makena: New Randomized Trial May Only Happen If Drug Stays On The US Market

 
• By Sue Sutter

Covis declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.

Makena mist
Covis declined to offer a clear view on whether it would do another trial in Makena were removed from the market. • Source: Shutterstock

Covis Pharma has declined to commit to conducting a new randomized, placebo-controlled trial Makena (hydroxyprogesterone caproate injection, also known as 17-OHPC or 17P) if the US Food and Drug Administration orders the preterm birth prevention drug off the market.

At the second day of a hearing on the Center for Drug Evaluation and Research’s proposal to withdraw Makena’s accelerated approval, Raghav Chari, Covis’ chief innovation officer, said currently available data from physician and patient surveys

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