Cholesterol drug delay signals new FDA standards

In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Researchers for the two companies say they now plan to file for approval in 2010. Shares of both companies were hurt by the announcement, with Isis shares dropping 29 percent Friday.

Genzyme agreed to buy $150 million of Isis shares and provide $175 million in a large upfront fee last January. The two companies planned to file for approval of mipomersen as a therapy targeted against a rare genetic disease. The decision, though, could have a wide ranging impact on drug developers if the FDA will no longer approve a drug based simply on its ability to lower cholesterol. And that could be a direct result of the brouhaha over data showing that Vytorin--while effective in lowering cholesterol--was no better than a generic in preventing thickening of the arteries.

- see this Genzyme/Isis release
- read the story in the Wall Street Journal

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