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
UsernamePublicRestriction

Vertex Phase III For CF Combo Shows Power Of “Breakthrough” Designation

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pivotal trials for the combination of Kalydeco and VX-809 will measure safety and efficacy over 24 weeks, whereas Kalydeco monotherapy gained FDA approval on the basis of 56 weeks of data; Vertex and FDA developed the protocol together following a recent “breakthrough therapy” designation for the two-drug combo.

You may also be interested in...



Fourth Quarter Earnings Calls, In Brief

Vertex/FDA in discussions on “breakthrough therapies”; Ipsen earnings hurting in EU; Pfizer discusses biosimilars; Krka likes emerging markets; Novo sees GLP-1 market competition stiffening

FDA’s First Breakthrough Designations Continue Vertex Kalydeco’s Regulatory Successes

Label expansion efforts for Vertex’s cystic fibrosis therapy will be claims taken through FDA’s new review pathway; the initial product could reach more patients more quickly and serve as a guide to how the agency will handle drugs earmarked for streamlined development and approval.

Warning Letter Roundup & Recap – 22 September 2020

No device-related warning letters were released by the US FDA the week of 22 September.

Topics

Related Companies

UsernamePublicRestriction

Register

ID1122310

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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