Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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 Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal

Executive Summary

Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.

You may also be interested in...



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.

US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

US FDA’s Drugs Center Wins Round One In Makena Dispute With Covis On Document Production

Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144831

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