Tanezumab is an intravenous monoclonal antibody that targets nerve growth factor.8 It’s a selective neurotrophin nerve growth factor mediator, in phase 3 clinical trials for treating pain conditions, including osteoarthritis (OA). In 2010, the FDA placed a partial clinical hold on the agent due to numerous case reports of suspected osteonecrosis that necessitated total joint replacements. A subsequent data review determined that of all the “potential” cases, only two were truly osteonecrosis. In August 2012, the FDA lifted the “partial clinical hold” but placed a new one in December 2012 due to peripheral nervous system effects observed in animals. The tanezumab program is currently subject to a partial clinical hold by the FDA, pending submission of additional nonclinical data. The manufacturer is planning to continue developing the agent for treating OA, chronic low back pain and cancer pain.
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A supplemental New Drug Application (sNDA) has been FDA approved for tofacitinib citrate 5 mg tablets, which includes radiographic data from two phase 3 studies in patients with RA. Reduction of radiographic progression was noted in the six-month ORAL Scan (Study IV; 5 mg BID or 10 mg BID tofacitinib) and ORAL Start (Study VI) studies.9 In Study IV, 74% MTX plus placebo tofacitinib-treated patients had no radiographic progression at Month 6, while 84% of tofacitinib 5 mg twice daily (BID) plus MTX-treated patients had no radiographic progression at Month 6. Patients who received tofacitinib 10 mg BID had similar results (79% had no mean progression of structural damage). In the ORAL Start study, 55% of MTX-treated patients had no radiographic progression at Month 6, while 73% of tofacitinib 5 mg BID plus MTX-treated patients had no radiographic progression at Month 6, which was sustained to Month 12. The primary end point was the mean change from baseline in modified total sharp score (mTSS) at Month 6. Tofacitinib is only FDA approved at the 5 mg BID dosage or 5 mg daily in patients with severe renal or hepatic impairment.
Michele B Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City, a Pharmacist at New York Presbyterian—Lower Manhattan Hospital, and Adjunct Faculty at Touro College of Pharmacy, New York City.
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