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

Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures

Executive Summary

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

You may also be interested in...



Fighting Accelerated Approval Withdrawal Hinders Other Sponsors' Applications, FDA’s Pazdur Says

Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous’ withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced.

Amylyx’s Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data

Company makes good on vow at a September 2022 advisory committee meeting to withdraw the ALS drug if the PHOENIX trial failed. That pledge served as a backstop to FDA’s approval decision based on a single study and created a level of sponsor accountability that often is missing when postmarketing studies fail.

Accelerated Approval Now Starting Point For Gene Therapy Development, US FDA’s Marks Says

Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149843

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