礼来公司的Foundayo获得欧洲关键监管小组的支持，使减重药物有望在更多主要市场获批。
Lilly & Co.’s Foundayo won the backing of a key European regulatory panel, putting the weight-loss pill in line for approval in additional major markets.
根据一份声明，欧洲药品管理局人用药物委员会周五建议批准每日一次服用的药片（亦称orforglipron），用于治疗肥胖和2型糖尿病。该建议现提交欧盟委员会作出最终决定，通常在约两个月后作出。
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the once-daily pill, also known as orforglipron, for obesity and type 2 diabetes on Friday, according to a statement. The recommendation now goes to the European Commission for a final decision, which typically follows within about two months.
Foundayo于4月获美国批准，成为继诺和诺德A/S口服Wegovy之后第二款获批用于减重的GLP-1类药物。美国食品药品监督管理局在加快审查程序后批准了该疗法，该程序是一项旨在加速获批被视为国家卫生优先事项的药物的新计划的一部分。
Foundayo won US approval in April, becoming the second GLP-1 pill cleared for weight loss after Novo Nordisk A/S’s oral Wegovy. The Food and Drug Administration authorized the treatment after an expedited review, part of a new program aimed at accelerating access to medicines considered national health priorities.
该药片是礼来扩大其在蓬勃发展的肥胖市场主导地位、接触偏好口服治疗而非注射的患者的重要战略组成部分。与诺和的药片不同，Foundayo可在不限制饮食或饮水的情况下服用。
The pill is an important part of Lilly’s strategy to expand its dominance in the booming obesity market and reach patients who prefer oral treatments to injections. Unlike Novo’s pill, Foundayo can be taken without restrictions on food or water.
在后期临床试验中，服用最高剂量的患者在72周内平均减重约占体重的11%，而接受安慰剂的患者减重约为2%。
In a late-stage clinical trial, patients taking the highest dose lost an average of about 11% of their body weight over 72 weeks, compared with roughly 2% for those receiving a placebo.
礼来表示，Foundayo在美国的初始推出速度低于分析师预期，因为医生和患者需要时间适应一种全新的药物。此后，礼来加大了营销力度，包括与玛莎·斯图尔特的新合作，这有助于提升消费者认知。
Foundayo’s initial US launch was slower than analysts expected, as doctors and patients got comfortable with an entirely new medication. Lilly has since ramped up its marketing, including a new with Martha Stewart, which is helping to drive more consumer awareness.
礼来美国业务负责人Ilya Yuffa表示，目前需求正在增长，他说，超过30%刚开始使用减重药物的患者选择了礼来的药物。
The company now sees demand increasing, according to US business chief Ilya Yuffa, who said more than 30% of patients newly starting a weight-loss pill are choosing Lilly’s drug.
“我们开始看到一些进展，”尤法在9月的投资者会议上说。“而这只是过去两个月新项目启动的显著改善。”利礼已经在一些国际市场推出，包括英国和阿拉伯联合酋长国。根据尤法的说法，该公司已在约40个国际市场提交Foundayo以获取批准。
“We’re starting to see some progress,” Yuffa said at an investor conference in September. “And that’s a marked improvement just in the last two months of new starts.”Lilly has already launched in some international markets, including the UK and United Arab Emirates. It’s submitted Foundayo for approval in about 40 international markets, according to Yuffa.
“只要获得批准，我们的计划就是启动，”尤法说。“我们有充足的供应。商业团队已经准备就绪。因此，这仅仅是这些批准时间的问题。”
“As soon as we get approvals, our plan is to launch,” Yuffa said. “We have supply readily available. Our commercial teams are ready. And so it’s just a matter of the timing of those approvals.”