Regeneron Pharmaceuticals has announced that it is suspending its trials of an osteoarthritis pain drug after it was issued a “clinical hold” by the FDA. This comes after promising reports of the company’s progress on the medication. For more information on this FDA hold and what it means for you and many other similar types of medication, keep on reading after the jump.
Regeneron and its partner Sanofi-Avantis SA were issued a hold by the FDA last week to halt trials and development of its osteoarthritis pain drug after a patient in a different trial developed a serious bone condition that is expected to affect the development of all similar drugs.
The patient in the other company’s drug trial, which has not been named by the FDA, developed a serious bone condition called avascular necrosis of the joint. This is caused by an insufficient blood supply reaching the bone, causing the bone tissue to deteriorate and die eventually resulting in the bone collapsing.
The Regeneron drug, which is called REGN475/SAR164877, is designed to block the nerve growth factor protein (NGF) to reduce pain from osteoarthritis and other joint conditions. Another similar drug by Pfizer was also put on hold earlier this year after trial patients began requiring joint replacement surgeries.
Though Regeneron and Sanofi-Avantis SA have reported that there are no active trials of their drug at the moment, and no clinical patients are being treated with the drug, they were issued a hold until the FDA decides what to do with this class of medication. Since health concerns seem to be consistently reported with anti-NGF class drugs, the FDA is considering changes or regulations for new class drugs in the future, and feel they may need t be implicated across the board and not on a case-by-case basis.
What do you guys think of the FDA putting a clinical hold on the Regeneron/Sanofi-Avantis SA osteoarthritis pain drug? Do you think all anti-NGF class drugs should be put on hold or denied FDA approval? Let us know what you think of this topic by leaving us some comments, and be sure to check out the informational video about osteoarthritis and pain below.