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

Executive Summary

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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Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period

Makena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure accurate patient and provider education after an accelerated approval drug’s confirmatory trial fails and/or during the period in which the agency is considering pulling the product from the market. 

Real-World Evidence: CDER, Covis Flipped The Script For Leveraging Makena Observational Studies

US FDA’s drugs center defended its use of observational studies and randomized trials in other populations to argue that evidence of Makena’s efficacy in preventing preterm birth is lacking; Covis’ expert said observational studies have little to contribute and trials in non-indicated populations are irrelevant.

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

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declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.

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