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

SYNTEX TICLID RECEIVES APPROVAL RECOMMENDATION FOR NARROW INDICATION

Executive Summary

SYNTEX TICLID RECEIVES APPROVAL RECOMMENDATION FOR NARROW INDICATION: the prevention of stroke recurrence in men and women intolerant to aspirin, providing there is bi-weekly monitoring for neutropenia. FDA's Cardio-Renal Drugs Advisory Committee unanimously voted to recommend the restricted indication for Ticlid (ticlopidine) at its Dec. 14 meeting. The advisory committee agreed that Ticlid was at least as effective as aspirin in preventing strokes. Commenting on the Ticlopidine American Stroke Study (TASS), committee member Salim Yusuf, National Heart, Lung, and Blood Institute, noted that, "if anything, [we have] seen a slight trend in favor of ticlopidine on major vascular events. I'm very comfortable saying, at the very least, [Ticlid] is equivalent to aspirin as an effective antiplatelet therapy." However, the committee felt that the 1% incidence of neutropenia in patients taking Ticlid precludes the product's use in the general, at-risk population of patients that have had a stroke or a transient ischemic attack (TIA). The committee recommended that labeling require careful monitoring for neutropenia by monitoring patient blood counts. Syntex had been seeking a much broader label for Ticlid, including: reduction of the combined risk of nonfatal stroke and death from all causes in women and men who had strokes or TIAs; reduction of combined risk of vascular death, nonfatal stroke, or nonfatal myocardial infarction (MI) in men and women who have had thromboembolic strokes, and reduced risk of recurrent stroke and stroke mortality in persons having thromboembolic strokes. The company presented the results of two major trials: TASS and the Canadian Ticlopidine Study (CATS). TASS was a triple-blind, multicenter trial involving 3,069 patients who had ischemic events such as strokes or TIAs ("The Pink Sheet" Aug. 28, 1989, T&G-10). Half the patients were randomized to receive 500 mg of Ticlid daily and the other half took aspirin 1,300 mg daily. The primary endpoint was nonfatal stroke or death by all causes. Syntex Institute for Research Senior Staff Researcher Sharon Anderson, PhD, pointed out that the risk reduction with Ticlid did not remain consistent over time. "In the first year, based on the intent to treat analysis, there's a risk reduction of 42% [in nonfatal death and stroke from all causes]. This is highly significant," Anderson said. She added that Ticlid "significantly reduces the risk of nonfatal or fatal stroke over aspirin [by .7%] in the first year." The CATS trial was a triple-blind, placebo-controlled study involving 1,073 patients at risk of recurrent stroke ("The Pink Sheet" July 3, 1989, T&G-8). Patients were randomized to either Ticlid 500 mg daily or placebo. The primary endpoint was fatal and nonfatal stroke, nonfatal MI, and cardiovascular death. Anderson noted that Ticlid showed a "reduction in risk of 22% based on the intent-to-treat analysis." Committee member Frank Harrell, Jr., PhD, Duke University Medical Center, said that Ticlid's effectiveness in the CATS trial was "seen in stroke, fatal and nonfatal, and it's almost seen in cardiovascular death." Regarding the occurrence of deaths, Harrell noted that in the CATS trial "there were 66 deaths in the ticlopidine group, 65 deaths in the placebo." Also there was "a slight difference in favor of ticlopidine in terms of cerebrovascular deaths," Harrell pointed out, 31 in the drug group and 40 on placebo. The committee also determined that it could not recommend approval for use of Ticlid in patients intolerant to aspirin to reduce the risk of death due to all causes or specified causes because the data lacked the power to identify an effect on mortality. Temple suggested that the labeling could "hint" at an effect on vascular death. He proposed that "in the population we're talking about...it's used to prevent stroke, and then to describe somewhere in labeling what the general jist of the studies were, [that] one can't single out particular types of events rigorously, but that there seems to be a similar effect on both fatal and nonfatal events."

You may also be interested in...



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

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

GB140150

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