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

WARNER LAMBERT's COGNEX: FDA ADVISORY COMMITTEE UNABLE TO RECOMMEND APPROVAL

Executive Summary

WARNER LAMBERT's COGNEX: FDA ADVISORY COMMITTEE UNABLE TO RECOMMEND APPROVAL due to unresolved questions regarding the efficacy of tacrine for the treatment of Alzheimer's disease. In a marathon March 15 session, FDA's Peripheral & CNS Drugs Advisory Committee adjourned at 10:15 p.m. without determining whether the sponsor's two pivotal trials established efficacy or were adequate and well-controlled." The committee did not move on to discuss tacrine safety or marketability issues. The committee could decide only that the dose-titration portion of Warner-Lambert's double-blind, placebo-controlled, multi-center study (protocol 970-1) showed some statistically significant "small effect" as measured by one objective efficacy assessment (the ADAS-Cognitive subscale). The committee found that the positive effect seen in the second pivotal trial, conducted by Shire Pharmaceutical, was "confounded" by complicating factors, including concomitant use with lecithin. Tacrine was studied under an expedited clinical trial protocol agreed to by FDA, Warner-Lambert and the National Institute of Aging. Calling the protocol "a gamble" because of the short-cuts is allowed, committee acting chairman Steven Ferris, PhD, New York University Medical Center, indicated that the committee would have been more persuaded by the data if it had shown "clean, clear-cut" evidence of substantial improvement in the assessments of cognitive function. Ronald Cresswell, PhD, Warner-Lambert Pharmaceutical Research Division VP and chairman, informed the advisory committee very late in the meeting that there are other tacrine trials ongoing and that his company will make the data available to FDA. He cautioned, however: "I don't see any likelihood" that this additional data will appear before a year to a year-and-a-half." In the meantime, Alzheimer's patients would be deprived of a therapy that did show some drug effect, Cresswell concluded. Ferris responded: "I don't think we should be influenced by what I would portray as an emotional side to this story," noting that the committee had to make a "considered judgment" based solely on the available evidence.

You may also be interested in...



Amylyx’ Second Chance Advisory Committee: Two Quasi-Precedents

US FDA’s plan to reconvene an advisory committee for a second look at Amylyx’ ALS drug AMX0035 is a remarkable twist in the ongoing review. It is essentially unprecedented, though there are two examples from the 1990s that offer some parallels.

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Latest Headlines
See All
UsernamePublicRestriction

Register

PS018907

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