Pfizer Suspends Tanezumab Osteoarthritis Clinical Trial Program

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 24 Jun 2010 - 2:00 PDT

email to a friend   printer friendly   opinions  

Pfizer Inc. (NYSE: PFE) announced the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the U.S. Food and Drug Administration (FDA). The worldwide suspension which is effective immediately follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab.

The clinical hold includes both the suspension of recruitment of new patients and the dosing of existing patients in the osteoarthritis program, as well as patients with osteoarthritis in other studies. The FDA as asked that, later this week, the company present its assessment of the potential implications of the adverse events in the osteoarthritis program for the other tanezumab clinical programs involving non-osteoporosis patients, which include patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy. The company is actively working with the FDA, to determine the appropriate course of action, which will serve the best interest of patients.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

Source: Pfizer Inc

• Additional
• References
• Citations