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

US FDA Grants RMAT Requests At Similar Rate To Breakthrough Designations

Executive Summary

Over the first five years of the regenerative medicine advanced therapy designation, analysis by the Pink Sheet finds the 40% success rate of requests is comparable to the broader breakthrough therapy designation, despite less stringent RMAT criteria.

You may also be interested in...



Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too

The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.

New RMAT Designations Include Autolous’ CAR-T, Direct Biologics’ Extracellular Vesicles And Allovir’s Antiviral T-cells

Latest regenerative medicine advanced therapy awards from US FDA address B-cell acute lymphocytic leukemia, acute respiratory distress syndrome associated with COVID-19, infection risk in stem cell transplant patients, and an ultra-rare form of severe combined immunodeficiency.

AlloVir Gains Third RMAT Designation For Antiviral T Cell Therapy

Gaining the special regulatory status in a prophylactic setting for posoleucel is the most significant yet for the T cell therapy developer.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146014

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