This article is more than 5 years old. Information may no longer be current.
FDA puts experimental OA drugs on hold
Click Here to Manage Email Alerts
According to a Securities and Exchange Commission filing dated Dec. 27, Regeneron Pharmaceuticals, Inc. announced the FDA has placed a nerve growth-factor inhibitor it is developing with sanofi-aventis on clinical hold.
The drug REGN475/SAR164877, an experimental pain drug for osteoarthritis (OA), was put on hold by the agency because of a confirmed case of avascular necrosis that was seen in another company’s anti-nerve growth factor (NGF) program, according to the Regeneron filing.
The NGF class of drugs works by inhibiting the protein that is associated with pain.
AstraZeneca also announced it was voluntarily putting a hold on its NGF inhibitor MEDI578 and Johnson & Johnson said it is putting trials of its drug fulranumab on hold at the request of FDA, also due to concerns over possible increased joint damage caused by the drug class.
“The FDA indicated that it is concerned that fulranumab and drugs of the anti-NGF class may be associated with a condition representing either rapidly progressive osteoarthritis or osteonecrosis,” Johnson & Johnson noted in a company-issued statement. “These conditions may result in the need for total joint replacement. We will work with the FDA toward resolution of this issue.”
In June FDA put a hold on Pfizers’ NGF inhibitor, tanezumab, when it was found the drug may accelerate OA symptoms in long-term studies.