2014年12月29日讯/生物谷BIOON/--诺和诺德的liraglutide（利拉鲁肽）获得FDA批准，将以商品名Saxenda打入美国的减肥药市场。
此前，Victoza已获FDA批准，用于2型糖尿病的治疗，有助于降低病人的血糖浓度。Saxenda与Victoza相比，只是剂量有所增加。
长期试验表明，liraglutide（利拉鲁肽）能够有效减轻患者体重，FDA近来批准Saxenda（liraglutide注射剂）作为治疗慢性肥胖的药物，作为饮食控制和体育锻炼的补充。
该药物的适应人群是体质指数（BMI）大于或等于30 的成年人，或者是那些体质指数为27及以上、伴有高血压、2型糖尿病或高胆固醇等至少一种肥胖并发症的成年人。
近期的研究表明，一半病人在服用Saxenda后体重至少减轻了5%，而竞争药的效果仅能达到2—5%，比单纯节食和锻炼的效果要好。
Victoza作为诺和诺德成功的主打产品，去年在糖尿病市场为诺和诺德斩获20亿美元的销量，比2012年的数据高27%。据分析员估计，此番Saxenda获批将会为额外为诺和诺德带来至少24亿美元的年收益。
这或许将改变减肥药市场在传统制药市场的刻板印象，自1999年罗氏的Xenical (orlistat)上市以来，业内通常认为减肥药不能成为收益的主要来源，而这次诺和诺德能否创造历史？
过去两年中，还有另外三种减肥药也获得了FDA的批准，分别是Orexigen的Contrave， Vivus的 Qsymia (phentermine/topiramate) 和 Arena Pharmaceutical的Belviq (lorcaserin)。然而它们却没有真正打开减肥药市场，Xenical一年的收益是4亿美元，而另外两种加起来也没有达到1亿美元。
肥胖在美国是一个严重的问题，并且愈演愈烈。对于那些BMI指数高的人群来说，肥胖会引发其他的病症，这也是以后治疗的重要靶点。
据美国疾病控制和预防中心表示，三分之二的美国成人超重或肥胖，2010年，美国成人的肥胖人数至少是1980年的2倍。
此前批准的减肥药还有一大缺陷，就是潜在的副作用大，主要集中于心脏问题，这也限制了这些药物潜力的发展。
Saxenda或许能改变这一局面，在过去四年用于治疗糖尿病的过程中，医生并未发现Saxenda会引发心血管方面的问题（尽管可能会增加患胰腺炎的风险）。
但是Saxenda也存在劣势。与传统减肥药的片型剂相比，Saxenda是注射用药，可能会因此影响销售。因为注射Saxenda的每日成本是40美元，而口服其它减肥药每日仅需花费5—6美元。
然而，基于Victoza此前的安全性，Saxenda战胜其它减肥药的销量也是指日可待。
原文： FDA approval for Novo Nordisk's obesity shot
Novo Nordisk has won US approval for a new formulation of liraglutide， which it will brand as Saxenda as the Danish firm looks to enter into the tough but potentially lucrative obesity market.
A lower dose form of the drug is already approved in the US and sold as Victoza， which has a US licence for certain type II diabetes patients to help lower their blood sugar levels.
Trials of the drug have long shown it can also help reduce patients' weight， and the FDA has now licenced Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
The drug is specifically approved for use in adults with a body mass index (BMI) of 30 or greater， or for adults with a BMI of 27 or greater who have at least one weight-related condition such as hypertension， type II diabetes， or high cholesterol.
A recent study showed that half the patients given Saxenda lost at least 5% body weight， the FDA said. Rival drugs show 2-5% weight loss， over and above diet and exercise.
The drug has already been a major success story for Novo Nordisk as a diabetes treatment， bringing in just over $2bn in sales last year， up 27% on its 2012 figures.
Its new licence will， according to analysts， help the drug deliver even more sales， with an extra $2.4bn in revenue expected to be brought in for the company.
This could be a game changer for the obesity market which has failed to be a major revenue driver for pharma since the first approval of Roche's Xenical (orlistat) in 1999.
In the last two years three other drugs have gained US marketing approval， including： Orexigen's Contrave， Vivus' Qsymia (phentermine/topiramate) and Arena Pharmaceuticals' Belviq (lorcaserin).
But they have so far failed to make any real market， with Xenical bringing in around $400m a year with the others failing to make $100m collectively.
Obesity is a large and growing problem in the US with many co-morbidities attached to those with higher BMI scores， and there is the potential for a new treatment to be a major blockbuster.
According to the US Centers for Disease Control and Prevention， two-thirds of American adults are overweight or obese and the prevalence of obesity in the US more than doubled among adults from 1980 to 2010.
All of the previously approved drugs have however had to tread a tough regulatory path due to their serious potential side effects， predominantly over their effects on the heart， which have pegged back their blockbuster potential.
High sales potential
This could all change with Saxenda as analysts expect the drug to do well given that it has been used for four years by doctors for diabetes， and has not faced the same cardiovascular safety concerns as many of its rivals (although there have been safety issues over its increased risk of pancreatitis).
But Saxenda does have some other issues as it does not come in pill form， as its rivals do， but rather as an injection， which could hamper sales.
Price may also be an issue as analysts expect the injection to be priced at about $40 per day - compared with an average of $5 to $6 per day for rival drugs.
However， the treatment is expected to have a better chance of being covered under Medicare and Medicaid drug payment programmes than rival drugs due to Victoza's established safety profile.