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Aegerion’s Juxtapid approved as new cholesterol treatment (but gets boxed)

December 24, 2012 10:25 am by | 0 Comments

(Reuters) - Aegerion Pharmaceuticals Inc said the U.S. health regulator approved its drug as an alternative treatment for patients who have a genetic predisposition to high cholesterol.

The drug, Juxtapid, would carry a boxed warning -- the strongest label warning -- and will be available only through a restricted program due to risk of liver damage.

Shares of the company fell nearly 4 percent to $24.76 in early trade on the Nasdaq on Monday.

Aegerion will also conduct a post-approval study to test the long-term safety and efficacy of Juxtapid, the company said on a conference call. It plans to launch the drug in January.

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Juxtapid, Aegerion's first approved product, was backed by an advisory panel of independent experts on October 17. The panel looks at a drug's approval application and advises the FDA on whether it should be approved.

The panel also recommended a drug from Sanofi SA and Isis Pharmaceutical Inc, Kynamro, to treat the same disorder on Oct 18.

Aegerion's shares were down 2 percent at $25.15 in morning trade. The stock has gained about 23 percent since the FDA panel's report to Friday's close.

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