European regulators won't back Amgen/UCB drug

安进公司骨质疏松症药物Evenity遭欧洲监管机构风险警示

2019-07-01 07:45:00 pharmamanufacturing

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Amgen and Belgian partners at UCB announced that the EMA has adopted a negative opinion on Evenity, for the treatment of osteoporosis in men and in postmenopausal women at increased risk of fracture. The opinion of the Committee for Medicinal Products for Human Use (CHMP) is based on results from a large development program including three pivotal Phase 3 studies comprised of nearly 12,000 patients. The osteoporosis drug was approved by the U.S. FDA in April 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, but will come with the agency’s strictest warning — a boxed label restricting women who have had a heart attack or stroke in the previous year from using the medication. The drug is also approved in Japan, South Korea and Canada. The companies intend to submit a written notice for a re-examination by the CHMP.
安进(Amgen)和比利时的合作伙伴在优时比(UCB)宣布, EMA 已经通过了一个负面意见的晚期性,治疗骨质疏松的男性和绝经后妇女在骨折风险增加。 人类用药品委员会( CHMP )的意见是基于一个大的发展计划的结果,包括三个关键的第三阶段研究,由近12,000名患者组成。骨质疏松症药物于2019年4月获得美国 FDA 批准,用于治疗绝经后高骨折风险妇女的骨质疏松症,但该机构将发出最严格的警告——这是一个盒装标签,限制上一年心脏病发作或中风的妇女使用该药物。 该药物还在日本、韩国和加拿大获得批准。 公司拟向 CHMP 提交复试书面通知。

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