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

What Makes A “Breakthrough”?

This article was originally published in RPM Report

Executive Summary

FDA is still not ready to draw any clear line defining what qualifies for the new “Breakthrough” therapy designation, but most successful applicants have presented data showing more than a 50% improvement versus standard therapy on some important endpoint.

You may also be interested in...



Following Through On Breakthrough: What’s Next For FDASIA Success?

FDA is building a case for enhanced funding to support the “Breakthrough” therapy program and at the same time is working to educate sponsors on how to use the new program effectively. The 21st Century Cures process floated a proposal for a new “Breakthrough” approval pathway – though that idea has been dropped. Still, it sets up an interesting discussion heading into 2017.

A Peak Year For Drug Approvals, But Can R&D Keep Up With FDA?

FDA topped 40 new molecular entity approvals in 2014, leaving no doubt that the agency’s drug review group is operating at peak efficiency. But it is still far from clear that drug development is out of the doldrums.

FDA’s “Breakthrough” Evolves: What’s Next For The Popular Program?

FDA’s second wave of Breakthrough Therapies will look markedly different from the initial flurry of approvals. After an early focus on oncology, FDA is reviewing a more diverse set of applications in the antiviral, vaccines and cardiovascular arenas. And there will be more “breaks” during development as sponsors start to request designations based on earlier data. What will Breakthrough look like in the third year of the program?

Related Content

Topics

UsernamePublicRestriction

Register

PS079769

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