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

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

Executive Summary

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declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.

You may also be interested in...



FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’s Advice

In a memo to Commissioner Califf and Chief Scientist Bumpus, Celia Witten focuses the final Makena decisionmakers on the key factors she believes should be used to determine the drug’s market status.

US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close

Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.

Effectiveness Or Bust: Without Benefit, No Case For Keeping Makena On The Market, CDER Says

FDA Center for Drug Evaluation and Research officials say accelerated approval of Covis’ preterm birth prevention drug should be withdrawn because substantial evidence of effectiveness no longer exists – separate from any concerns about study feasibility, off-label use or compounding.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147163

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