BioCentury on BioBusiness,
Lots of dosing data wins over FDA panel for Boehringer's olodaterol LABA in COPD
Over the LABA hurdle
Monday, February 4, 2013
Generally positive comments from FDA reviewers and a panel's overwhelmingly positive vote for olodaterol to treat chronic
obstructive pulmonary disorder probably speak less about a change in U.S.
regulators' views about LABA safety than they do about the heft of Boehringer
Ingelheim GmbH's application.
By designing a robust clinical
development program for olodaterol that included multiple studies designed to
show a clear dose response, Boehringer sidestepped the problems that caused FDA
to send the last long-acting adrenergic receptor beta 2 it reviewed back to the
drawing board to establish the lowest effective dose.
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 Subscription 4 Weeks of Access
BioCentury's Weekly Business Intelligence Journal
Get a 4-week free trial subscription to BioCentury.
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 ]