US FDA puts stops on Johnson & Johnson's fulranumab and Regeneron/Sanofi-Aventis osteo drug due to side effect risks

4 January 2011

US health care giant Johnson & Johnson (NYSE: JNJ) has halted studies of experimental painkillers due to concerns that a class of drugs known as anti-nerve growth factor (NGF) agents may raise the risk of joint damage, Bloomberg News reported last week, after the US Food and Drug Administration notified J&J that development for the drug fulranumab had been put on hold, a spokesman for the company said in an e-mail to the news service.

Earlier this year, global drugs behemoth Pfizer (NYSE: PFE) announced the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the FDA (The Pharma Letter June 24, 2010). The worldwide suspension - which took effective immediately - follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement.

Partly as a result of the Pfizer findings, according to Bloomberg, Anglo-Swedish drug major AstraZeneca (LSE: AZN) voluntarily stopped early-stage studies of its anti-NGF drug candidate medi578. The suspension was not requested by regulators and the company has not seen similar cases of bone-tissue death.

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