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【编译】Merck他汀OTC遭拒，Sanofi-Aventis新脑炎疫苗
由于担心降胆固醇药物在没有医生指导下, 会出现安全问题, 上星期五美国FDA顾问委员会以20比3投票敦促FDA拒绝Merck公司降胆固醇药物Mevacor的OTC药上市申请。尽管最终的生杀大权在FDA手里, FDA通常会采纳顾问的推荐。
顾问委员会认同Merck公司的OTC产品(20-milligram Mevacor)的制剂量对特定病人群体降低心脏病发作风险是有帮助, 但考虑到怀孕妇女可能会用该药物,或者健康人用该药可能会遇到诸如肌肉受损害等较为罕见的副作用, Merck公司的OTC产品还是没能得到多数委员的上市推荐。当然还是有少数委员投票赞成让OTC他汀上市, 他们的理由是应该让更经济更方便地让普通底收入的百姓享用降胆固醇药物, 对降低全美国心脏病发生率有帮助。新墨西哥大学内分泌系的负责人大卫Schade先生就是这样认为的。
许多顾问小组成员表示他们会支持对于”他汀”类产品采取特别的”柜台后”出售, 也就是普通患者必须与药剂师沟通后才能得到药物。 Merck的他汀药OTC Zocor在英国, 就是以这样的方式和系统, 被批准出售的。
FDA从不认可在美国实施”柜台后”销售。FDAOTC药物部门的主任Ganley Charles先生说: 他不清楚是否FDA有权批准这样的药品上市方式, 但如果Merck或者另一个公司提出申请, FDA会加以考虑。
Merck和J&J对顾问委员会的投票决定表示失望, 这是Merck自2000年申请遭拒后， 再度受挫，但是Merck宣称将继续推动Mevacor”柜台后”销售的上市, 会与FDA继续交流沟通，Merck发言人托尼Plohoros说。
又讯： 脑膜炎新疫苗“Menactra“获准上市
同一天， FDA批准了法国药品制造商Sanofi-Aventis防止脑膜炎的新疫苗“Menactra“ 适合11-55岁人用。疫苗预期比Sanofi-Aventis老一代称为Menomune的疫苗更长效，Menomune在三到五年之后基本不起作用，公司解释说。 Menactra是用用新的技术被做的，其免疫效能可通过增添注射进一步加强。新疫苗的好处是，在幼年期接种，一直管用到念大学，那时会遇脑膜炎高危险期。
FDA Panel Rejects Merck OTC Drug
BETHESDA, Md. (Reuters) - A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales of Merck & Co. Inc.'s cholesterol-lowering drug Mevacor because of doubts the medicine could be used safely without a doctor's guidance.
The panel voted 20-3 against a proposal from Merck and Johnson & Johnson for a nonprescription, low dose version of Mevacor, part of the statin family of drugs used to lower cholesterol and heart disease risk.
The Food and Drug Administration usually follows the recommendations of the advisory panels.
The panel agreed the population Merck wanted to target - people with moderate heart attack risk - would be helped by the 20-milligram Mevacor dose. But many were concerned pregnant women might take the drug or otherwise healthy people would expose themselves to side effects such as rare cases of muscle damage.
They said Merck's research on consumer understanding of the package instructions did not provide assurance it would be used properly.
"I think it is the right thing to do, but I don't think we're there yet," said Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine.
Allowing Mevacor to be sold over the counter would be a major shift. Nonprescription drugs generally treat short-term conditions with easily recognized symptoms such as a headache or runny nose. High cholesterol can be detected only with a blood test, and patients often take statins for years.
The FDA rejected earlier proposals for nonprescription statins from Merck and others, most recently in 2000.
The few panelists who voted for the Mevacor switch said wide access to a statin would help curb the U.S. epidemic of heart disease, the nation's leading killer.
"There are millions of Americans in this country with no health insurance and absolutely no access to a statin. I think these people deserve the right to lower their risk and prevent cardiovascular disease," said Dr. David Schade, chief of endocrinology at the University of New Mexico.
Many panelists voiced support for selling statins "behind-the-counter," which would drop the prescription requirement but force people to talk to a pharmacist to get the drugs. Merck's statin Zocor is sold under such a system in Britain.
The FDA has never approved "behind-the-counter" sales in the United States. Dr. Charles Ganley, director of the FDA's over-the-counter drugs division, said it was unclear if the agency could legally approve such a scheme but regulators would consider it if Merck or another company asked.
Merck and Johnson & Johnson were disappointed by the panel vote but will continue to work with the FDA on moving Mevacor over the counter, Merck spokesman Tony Plohoros said.
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作者:admin@医学,生命科学 2011-06-21 17:16
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