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Sanofi Message Board

  • kmaggon kmaggon Dec 29, 2010 1:26 AM Flag

    REGN 475 Phase II Clinical hold

    SNY R&D suffers a setback with the FDA clinical hold on all NGF mabs. The FDA clinical hold stops all new patient recruitment and dosing with all the monoclonal antibodies acting on the nerve growth factor NGF. FDA considers all reported cases of drug related adverse reactions as a class toxicity issue unless proven otherwise by robust data. The reported adverse reactions were accelerated joint destruction and progression to surgery (16 cases out of 6800 patients treated with Tanezumab) and a case of avascular necrosis of a joint in a trial with a non disclosed drug. This clinical hold is valid for the Phase III trials with Tanezumab (Pfizer), Phase II trials with REGN 475 (Regeneron, Sanofi Aventis) and Phase I trials with Fulranumab (J&J) and MEDI 578 (Astra Zeneca). The market potential of anti NGF monoclonal antibodies for non addictive pain relief for months with a single injection was projected at 11 billion dollars. The QR code for article access by smart phones and multimedia devices:

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