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FDA says 'not yet' on Lilly's once-weekly Byetta

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Eli Lilly and Co. will have to wait a little longer before selling a once-weekly version of its diabetes drug Byetta.

The U.S. Food and Drug Administration told Lilly and its development partners on Byetta that it wants feedback on the new product’s label, clarification of its manufacturing processes and submission of a Risk Evaluation and Mitigation Strategy.

Lilly and San Diego-based Amylin Pharmaceuticals Inc., said they will respond in the next few weeks. They plan to sell the drug under the brand name Bydureon.

But significantly, the FDA said it would require no further testing of Bydureon, which would have threatened to delay its launch much longer.

"In this scenario, we'd anticipate a second-quarter resubmission and a fourth-quarter approval," JPMorgan analyst Cory Kasimov wrote in a research note, according to Reuters.

The drug approval is key for both companies. Byetta, taken as a twice daily injection, has been successful for controlling blood sugar levels in patients and helping some lose weight. It racked up $797 million in worldwide sales last year.

But analysts expect a once-weekly injection of Bydureon to be far more attractive because of its convenience. Analysts expect sales of Bydureon to reach as high as $2 billion by 2015.

Lilly and Amylin’s chances of approval were judged high after the FDA in January approved a similar drug, Victoza, a once-daily injection made by Denmark-based Novo Nordisk A/S.

Bydureon uses technology from Massachusetts-based Alkermes Inc. to release the compound exenatide at a controlled rate.

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  1. Doug Henning!

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  3. Magician and illusionist!

  4. The basic idea of nice apartments with parking and retail is a good one, but this design seems overwhelmingly big/tall for Broad Ripple. The size could be disguised a bit with lots of big trees/landscaping, but the complex is too massive to blend in easily. That section of canal between College and Westfield will also need to be upgraded on both sides. Nice apartments facing onto a nice promenade with shade trees/plantings could bring together the canal towpath/Monon recreation, the outdoor seating at existing restaurants, and this project into something that upgrades the whole area. A plan for the whole stretch makes more sense than facing nice new housing onto what looks like a ditch. Is there a plan? Does the public have input? Who pays? The apartment idea seems to be reasonable, but Whole Foods is not a good idea for appropriate retail. Besides the store being physically too big, there are already Fresh Market at 54xCollege and Whole Foods in Nora for fancy groceries. Good Earth and Kroger are within walking distance of the Shell site. There are at least 7 grocery stores within a safe bike ride. Whole Foods would add nothing but traffic congestion. This design is on the right track, but there needs to be more work done to ensure that it blends in with and enhances the existing community. A project that large will set a tone for that whole part of town. It could be a real asset, but only if done right.

  5. I did not move to Zionsville to live in Carmel. This and the subsequent developments to follow will ensure a vanilla uniformity of strip malls and apartment buildings as we seek to bring our town down to the least common denominator. We were warned before recent elections that pro-development council members would make sure their friends (landowners and developers) would be able to make their millions off of the exploitation of Zionsville. Why in God's name would we sell out the best preserved small town in the State of Indiana?

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