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【drug-news】阿斯利康的Brilinta（抗血小板聚集药物
The Food and Drug Administration asked for additional analysis of a study called Plato comparing Brilinta with Plavix in patients with severe chest pain or earlier heart attacks, the London-based company said yesterday in a statement. The twice- daily pill won a 7-1 recommendation from an FDA advisory panel on July 28.
The FDA’s decision delays a product whose sales may have reached $2.7 billion by 2015, according to the average estimate of three analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year.
Regulators didn’t ask for new clinical trials for the drug, known by its chemical name, ticagrelor, and “our highest priority is to provide the requested Plato analyses to the FDA,” Martin Mackay, AstraZeneca’s president of research and development, said in the company’s statement.
“The company remains confident in the submission for ticagrelor and in its ability to respond to the agency’s questions,” AstraZeneca said in its statement.
AstraZeneca gained 4 pence, or less than 1 percent, to 3,153 pence, in yesterday’s London trading. The drugmaker has gained 8.3 percent this year, compared with a 7.1 percent gain in the 17-member Bloomberg Europe Pharmaceuticals Index.
Rival Treatments
Brilinta would compete with Plavix from New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi-Aventis SA, and Effient, sold by Eli Lilly & Co. All three are pills designed to prevent platelets in the blood from clumping together to form clots, which can cause heart attacks and strokes. Plavix and Effient are taken daily and remain effective for one week after treatment is halted. Brilinta wears off more quickly, so it may pose a lower risk of bleeding for surgery patients.
In Plato, AstraZeneca’s key study of 18,624 people, 9.8 percent of patients on Brilinta for a year had a heart attack, stroke or died from cardiovascular disease, compared with 11.7 percent of those on Plavix. A related study also showed AstraZeneca’s drug was effective regardless of the patients’ genetic makeup, unlike Plavix, which doesn’t work in patients with a certain genetic variation.
Study participants in the U.S. and Canada did worse on Brilinta than people from other parts of the world. In backing the drug, the FDA’s advisers said in July the findings may be the result of chance and could be examined in a new trial after approval. FDA staff rejected AstraZeneca’s suggestion that higher U.S. aspirin use contributed to the outcome.
European Approval
Brilinta was approved this month in Europe, where it is known as Brilique. AstraZeneca will likely begin marketing the drug in the second half of 2011 once prices are negotiated with member countries, Sarah Lindgreen, a company spokeswoman, said Dec. 6.
AstraZeneca will market the drug based on the results of the study that showed a benefit over Plavix, Lindgreen said.
Plavix, introduced in 1997, had sales of $9.8 billion last year. Effient, approved in July 2009 with a boxed warning on bleeding risk, made $27 million last year for Indianapolis-based Lilly and its marketing partner, Daiichi Sankyo Co. of Tokyo.
Lipitor, a cholesterol pill made by New York-based Pfizer Inc., is the world’s best-selling drug with 2009 revenue of $11.4 billion.
http://www.bloomberg.com/news/2010-12-17/astrazeneca-fails-to-win-u-s-regulator-approval-for-plavix-rival-brilinta.html?cmpid=yhoo AZ损失大了 认领，48h内交稿，逾期请其他战友自由认领 请大家指正
AstraZeneca Fails to Win U.S. FDA Approval for Plavix Competitor Brilinta
波立维的竞争者——阿斯利康的替卡格雷未通过美国FDA的审批
The Food and Drug Administration asked for additional analysis of a study called Plato comparing Brilinta with Plavix in patients with severe chest pain or earlier heart attacks, the London-based company said yesterday in a statement. The twice- daily pill won a 7-1 recommendation from an FDA advisory panel on July 28.
总部位于伦敦的公司在昨天的发布会上说，美国食品药品监督管理局要求提供更多的Plato试验的分析结果，这一试验是对Brilinta和波立维应用于有严重胸痛或早期心脏病发作的患者进行比较研究的。7月28日，这一每天服用两次的片剂曾获得FDA顾问委员会7：1的推荐。
The FDA’s decision delays a product whose sales may have reached $2.7 billion by 2015, according to the average estimate of three analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year.
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作者:admin@医学,生命科学 2010-12-24 21:22
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