NEW YORK (AP) – The Food and Drug Administration placed studies of Regeneron Pharmaceuticals Inc. and Sanofi-Aventis’ potential osteoarthritis drug on hold because of potential harm to patients’ bones.
In a Securities and Exchange Commission filing on Monday, Regeneron said the Food and Drug Administration place studies of REGN475 on hold after a patient being treated with the same class of drug in another company’s study developed avascular necrosis of a joint.
Avascular necrosis, sometimes referred to as bone death, involves the cutoff of blood to the bone, causing the bone tissue to die and the eventual collapse of the bone.
REGN475, also called SAR164877, is a nerve growth factor inhibitor, which aims to block pain.
The FDA is concerned the side effect could be an issue with all drugs in the same class.
The company said there are currently no ongoing studies of REGN475.
In July, at the FDA’s request, Pfizer Inc. stopped testing its potential nerve growth factor inhibitor tanezumab for patients with chronic low back pain, nerve damage from diabetes and arthritis.
Date: December 27, 2010
Source: Associated Press
Filed Under: Drug Discovery