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

Roche’s Actemra Postmarket Safety Plan May Obviate Need For REMS

Executive Summary

Roche may have staved off the imposition of a REMS for its rheumatoid arthritis candidate Actemra by proposing a robust pharmacovigilance of its own

You may also be interested in...



Roche’s Actemra needs a REMS

FDA announced Dec. 4 that a Risk Evaluation and Mitigation Strategy will be required of Roche's Actemra (tocilizumab), possibly pushing its launch back to 2010, and sending a message to other companies that any drug proposed with a comprehensive safety plan will most likely require a REMS. Roche had proposed an extensive post-marketing plan to monitor safety for the novel rheumatoid arthritis drug, which paved the way for a positive advisory committee review (1"The Pink Sheet," Aug. 4, 2008, p. 11). Additional non-clinical studies are also required. Roche expects to re-submit Actemra, which received a "complete response" letter in September, in the third quarter of 2009

Roche’s Actemra needs a REMS

FDA announced Dec. 4 that a Risk Evaluation and Mitigation Strategy will be required of Roche's Actemra (tocilizumab), possibly pushing its launch back to 2010, and sending a message to other companies that any drug proposed with a comprehensive safety plan will most likely require a REMS. Roche had proposed an extensive post-marketing plan to monitor safety for the novel rheumatoid arthritis drug, which paved the way for a positive advisory committee review (1"The Pink Sheet," Aug. 4, 2008, p. 11). Additional non-clinical studies are also required. Roche expects to re-submit Actemra, which received a "complete response" letter in September, in the third quarter of 2009

Roche’s Actemra gets “complete response” letter

FDA's Sept. 18 "complete response" letter for Roche's rheumatoid arthritis biologic Actemra (tocilizumab) requests more details on labeling and manufacturing. Actemra would be the first IL-6 inhibitor to reach the U.S. market, if approved. Roche's pharmacovigilance plan, which could take the form of a Risk Evaluation and Mitigation Strategy, had eased the safety concerns of FDA's Arthritis Drugs Advisory Committee, which supported approval by a 10-1 vote in July (1"The Pink Sheet," Aug. 4, 2008, p. 11). No additional studies are requested and Roche is working with FDA to address questions and "define the path forward.

Related Content

UsernamePublicRestriction

Register

GB150348

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