Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
Executive Summary
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
You may also be interested in...
Makena Randomized, Controlled Trial Proposal Shows Evolution In Covis’ Thinking
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.
Accelerated Approval: Makena Real-World Evidence Insufficient To Verify Clinical Benefit, CDER Says
Covis seeks to discuss study proposals and other accelerated approval precedents at still-unscheduled withdrawal hearing; CDER says company’s current RWE proposal is inadequate given its design and the failure of the PROLONG confirmatory clinical trial.
Makena Accelerated Approval Withdrawal Hearing Should Be In-Person, Covis Tells US FDA
Covis cites challenges of conducting virtual meetings but leaves door open to hybrid approach. CDER wants advisory committee vote on feasibility of timely conducting new adequate, well-controlled trial, while Covis seeks vote on whether withdrawal is appropriate given absence of another approved drug for preventing preterm birth.