|
 The drug, obeticholic acid (OCA), is being reviewed for use in
patients with primary biliary cholangitis, a condition in which the
body mistakes the bile ducts in the liver as foreign objects and
tries to destroy their lining.
"If approved, we project launch in July and gross peak annual
worldwide sales could reach about $2.2 billion," Wedbush Securities
analyst Liana Moussatos said in a note this week.
Accelerated approval is given to drugs based on a surrogate endpoint
such as a radiographic image or laboratory measure that points to a
clinical benefit.
Surrogate endpoints are used when clinical trials may require too
many patients and the outcome may take too long.
Companies are required to conduct studies to confirm the anticipated
benefit. If a confirmatory trial does not prove such a benefit, the
FDA can revoke the approval.
(Reporting by Amrutha Penumudi and Rosmi Shaji in Bengaluru; Editing
by Don Sebastian)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
 |
