Development of anti-nerve growth factor drugs at two different companies has been suspended by the FDA after a serious bone disorder occurred in a study participant.
Regeneron, a Tarrytown, N.Y.-based biopharmaceutical firm, noted in a Securities and Exchange Commission filing on Monday that it had been notified by FDA that "a case confirmed as avascular necrosis of a joint was seen in another company's anti-nerve growth factor (NGF) program. The FDA believes this additional case provides evidence to suggest a class effect."
As a result, the agency put REGN475/SAR164877 -- an NGF inhibitor being developed jointly by Regeneron and sanofi-aventis -- on clinical hold, according to the filing.
The FDA defines a clinical hold as "An order issued ... to the sponsor of an investigational new drug to delay or suspend a clinical investigation."
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