Safety fears trigger FDA hold for Regeneron pain med trial

The FDA has placed Regeneron's ($REGN) trial for an experimental pain medicine on hold, signaling that the entire drug class it belongs to could be in big trouble. The hold was announced after a patient in a different study involving a similar drug developed avascular necrosis, or bone tissue death triggered by a lack of blood supply.

REGN475/SAR164877 is an nerve growth inhibitor much like Pfizer's tanezumab, which was put on hold last summer after patients in a trial required joint replacements. A spokesman for Pfizer told Bloomberg the FDA is examining all anti-nerve growth drugs now in development.

"The FDA believes this additional case provides evidence to suggest" bone problems for the entire class, Regeneron said in a filing. The drug is partnered with Sanofi-Aventis.

- see Regeneron's SEC filing
- here's the Reuters story
- get the Bloomberg report

Suggested Articles

Immunic's lead asset beat placebo at reducing damage to myelin, which protects nerve fibers, in patients with relapsing multiple sclerosis.

The appointment sees Kobayashi switch from developing Dermira’s anti-IL-13 drug to advancing Aslan’s would-be rival.

Lilly has created customized mobile research units to run the clinical trial as the long-term care facilities lack experience running studies.