Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?

Executive Summary

Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.

You may also be interested in...



A Conspicuous Absence: Professional Societies ACOG, SMFM Missing From Makena Public Hearing

The American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine did not testify at the public hearing on CDER’s proposal to withdraw the preterm birth prevention drug, even though the groups’ clinical guidelines still recommend use of Makena and its active ingredient.

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.

Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing

The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141115

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel