Mon Dec 24, 2012 10:25am EST
(Reuters) – Aegerion Pharmaceuticals Inc pronounced a U.S. health regulator authorized a drug as an choice diagnosis for patients who have a genetic proclivity to high cholesterol.
The drug, Juxtapid, would lift a boxed warning — a strongest tag warning — and will be accessible usually by a limited module due to risk of liver damage.
Shares of a association fell scarcely 4 percent to $24.76 in early trade on a Nasdaq on Monday.
Aegerion will also control a post-approval investigate to exam a long-term reserve and efficiency of Juxtapid, a association pronounced on a discussion call. It skeleton to launch a drug in January.
Juxtapid, Aegerion’s initial authorized product, was corroborated by an advisory row of eccentric experts on Oct 17. The row looks during a drug’s capitulation focus and advises a FDA on either it should be approved.
The row also endorsed a drug from Sanofi SA and Isis Pharmaceutical Inc, Kynamro, to provide a same commotion on Oct 18.
Aegerion’s shares were down 2 percent during $25.15 in morning trade. The batch has gained about 23 percent given a FDA panel’s news to Friday’s close.
(Reporting By Pallavi Ail in Bangalore; Editing by Sriraj Kalluvila)