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Lilly diabetes drug wins backing from EU regulator

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A European Medicines Agency panel recommended approving a diabetes drug from Boehringer Ingelheim GmbH and Eli Lilly and Co. that was rejected this month in the United States because of manufacturing deficiencies.

The medicine, Jardiance, should be approved as a treatment for type 2 diabetes, the agency’s Committee for Medicinal Products for Human Use said in a prepared statement Friday. The European Commission usually follows the panel’s advice.

Indianapolis-based Lilly is expected to garner $518 million in annual sales from Jardiance by 2019, according to the average of five analyst estimates compiled by Bloomberg.

The Food and Drug Administration said this month it wouldn’t approve the drug until Boehringer fixes the problems disclosed in May after a 2012 inspection of a plant in Ingelheim am Rhein, Germany, where the closely held company is based. The FDA completed its re-inspection of Boehringer’s plant March 7, the company said.

The treatment, also known as empagliflozin, is part of a class of medicines that includes Johnson & Johnson’s Invokana and AstraZeneca Plc’s Forxiga. The drugs help the body get rid of sugar through the kidneys. Type 2 diabetes, the most common kind, is often driven by obesity, as the body loses its ability to process sugar. The disease may be the seventh leading cause of death in the world by 2030, according to the World Health Organization.

 

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  1. A Tilted Kilt at a water park themed hotel? Who planned that one? I guess the Dad's need something to do while the kids are on the water slides.

  2. Don't come down on the fair for offering drinks. This is a craft and certainly one that belongs in agriculture due to ingredients. And for those worrying about how much you can drink. I'm sure it's more to do with liability than anything else. They don't want people suing for being over served. If you want a buzz, do a little pre-drinking before you go.

  3. I don't drink but go into this "controlled area" so my friend can drink. They have their 3 drink limit and then I give my friend my 3 drink limit. How is the fair going to control this very likely situation????

  4. I feel the conditions of the alcohol sales are a bit heavy handed, but you need to realize this is the first year in quite some time that beer & wine will be sold at the fair. They're starting off slowly to get a gauge on how it will perform this year - I would assume if everything goes fine that they relax some of the limits in the next year or couple of years. That said, I think requiring the consumption of alcohol to only occur in the beer tent is a bit much. That is going to be an awkward situation for those with minors - "Honey, I'm getting a beer... Ok, sure go ahead... Alright see you in just a min- half an hour."

  5. This might be an effort on the part of the State Fair Board to manage the risk until they get a better feel for it. However, the blanket notion that alcohol should not be served at "family oriented" events is perhaps an oversimplification. and not too realistic. For 15 years, I was a volunteer at the Indianapolis Air Show, which was as family oriented an event as it gets. We sold beer donated by Monarch Beverage Company and served by licensed and trained employees of United Package Liquors who were unpaid volunteers. And where did that money go? To central Indiana children's charities, including Riley Hospital for Children! It's all about managing the risk.

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