Pink Sheet is part of the Business Intelligence Division 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

Aubagio Approval Reflects FDA’s Evolving View On Multiple Sclerosis Drugs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sanofi’s teriflunomide is indicated broadly for treating relapsing forms of MS. The claim marks a departure from previously approved MS drugs, in which the specific effects seen in clinical trials are described in the Indications section. FDA said the Aubagio claim more closely reflects how physicians actually use the drugs and represents a more flexible regulatory approach that enabled approval of a second, lower dose.

Advertisement

Related Content

US FDA Eliminating 'Sub-Indications' From Inflammatory Bowel Disease Labels
Review Of Reviews: Drug Review Profiles 2013
Review Of Reviews: Drug Review Profiles 2013
Biogen Idec Undercuts Gilenya With $55,000 Yearly Price For Tecfidera
Biogen Idec’s Tecfidera Goes To Market With Claim For Delay Of Disability Progression
Lemtrada A Game Changer In MS, Genzyme Researchers Say
Biogen Leans On Plegridy To Help Extend The Life Of Avonex
Aubagio Clinical Development
FDA Looked To Arava’s Safety Experience In Gauging Aubagio’s Risks
Aubagio Reviewers

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS005358

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