BioCentury on BioBusiness,
Aegerion, Genzyme HoFH products clear FDA panel; how doctors will use is unclear
Related tables, figures and sidebars
Monday, October 29, 2012
If FDA follows its advisory panel's recommendation, Aegerion
Pharmaceuticals Inc. and Sanofi's
Corp. unit could each be launching new drugs to treat the ultra-Orphan
disease homozygous familial hypercholesterolemia early next year. But neither
the panel discussion nor the companies' clinical trials give doctors much of an
idea of how and when to use one drug over the other.
The 15 members of the
Endocrinologic and Metabolic Drugs Advisory Committee included only one doctor
who treats hoFH patients. The remaining members included hepatologists brought
in to discuss elevations in hepatic enzymes and hepatic fat seen with both
compounds, as well as statisticians, epidemiologists, endocrinologists,
cardiologists and a gastroenterologist.
words displayed of
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2015 BioCentury Publications, Inc. ALL RIGHTS RESERVED. All use of this Web Site and its contents is governed by the BioCentury User Agreement
. The contents of this Web Site are protected under U.S. and foreign copyright and intellectual property laws, and no part of this Web Site or its contents may be photocopied, reproduced or retransmitted in any form without the written consent of BioCentury, which may be requested from Reprints/Permissions
. BioCentury®; The Bernstein Report on BioBusiness™; The BioCentury 100™; The Clear Route to ROI™; Because Real Intelligence is Hard to Find™; BCIQ™; and BioPharma's Knowledge Center™; are trademarks of BioCentury Publications, Inc., P.O. Box 1246, San Carlos, CA 94070. SciBX® and SciBX: Science-Business eXchange® are trademarks of Nature America, Inc. that are jointly used by BioCentury Publications, Inc. and Nature America, Inc.
Whether you want an individual subscription or need a global group license, we have the products,
the experience and the customer support that biopharma executives, researchers, investors, service providers,
and industry stakeholders have trusted for nearly two decades.
Let our Subscriber Services team customize the best intelligence package available in the industry to meet your needs.
Free Trial 4 Weeks of Access
Get a 4-week free trial subscription to see the important articles you are missing.
Get 4 Weeks Free
Thanks for purchasing this article.
Please bookmark this url for future reference.
We have also sent you a confirming e-mail with a receipt and this same url for your
close [ X ]