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Lilly, partner find no Bydureon effect on heart rhythm

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Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said an analysis of a 148-patient trial found no evidence that their experimental Bydureon diabetes drug causes prolonged heart rhythms.

The analysis, released in summary form Sunday at the American Diabetes Association annual scientific meeting in San Diego, found the drug “did not affect” a heart rhythm called the QT interval, according to the abstract. The analysis includes data the companies previously submitted to the U.S. Food and Drug Administration.

Last October, the FDA refused to approve Bydureon, a weekly version of Indianapolis-based Lilly and San Diego-based Amylin’s diabetes drug Byetta. The agency asked the two companies and Alkermes of Waltham, Mass., to perform a new study looking at whether high levels of Bydureon can cause an abnormal heart rhythm that may increase the risk of sudden cardiac death. The study results will be available in the second half of this year, said Christian Weyer, senior vice president at Amylin.

The results of the current analysis “are very reassuring,” Weyer said. “Ultimately, we need to await the result of the ongoing study.”

The companies plan to resubmit Bydureon for approval “very shortly” after the ongoing study is completed, he said.

European regulators gave approval to Bydureon a week ago.

In other research from the meeting, the companies reported data from a 121-patient study finding that a once-monthly version of Byetta may produce similar blood sugar control to the weekly version of Bydureon over a 20-week period.

Byetta, a twice-daily injection that has been sold since 2005, generated $710.2 million in sales last year, according to Bloomberg data.

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  1. The free market will seek its own level. If Employers cannot hire a retain good employees in Marion Co they will leave and set up shop in adjacent county. Marion Co already suffers from businesses leaving I would think this would encourage more of the same.

  2. We gotta stop this Senior crime. Perhaps long jail terms for these old boozers is in order. There are times these days (more rather than less) when this state makes me sick.

  3. One option is to redistribute the payroll tax already collected by the State. A greater share could be allocated to the county of the workplace location as opposed to the county of residency. Not a new tax, just re-allocate what is currently collected.

  4. Have to agree with Mal Burgess. The biggest problem is massive family breakdown in these neighborhoods. While there are a lot of similiarities, there is a MASSIVE difference between 46218 and 46219. 46219 is diluted by some stable areas, and that's probably where the officers live. Incentivizing is fine, but don't criticize officers for choosing not to live in these neighbor hoods. They have to have a break from what is arguably one of the highest stress job in the land. And you'll have to give me hard evidence that putting officers there is going to make a significant difference. Solid family units, responsible fathers, siblings with the same fathers, engaged parents, commitment to education, respect for the rule of law and the importance of work/a job. If the families and the schools (and society) will support these, THEN we can make a difference.

  5. @Agreed, when you dine in Marion County, the taxes paid on that meal go to state coffers (in the form of the normal sales taxes) and to the sports/entertainment venues operated by the CIB. The sales taxes on your clothing and supplies just go to the state. The ONLY way those purchases help out Indianapolis is through the payroll taxes paid by the (generally low-wage) hourly workers serving you.

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