Pfizer has terminated its osteoarthritis clinical program for the investigational compound Tanezumab following a request by the FDA.
The worldwide suspension of the program, which is effective immediately, follows a small number of reports of Pfizer Tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement.
Pfizer said that, 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 has asked that Pfizer 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.
Pfizer is working with the FDA, to determine the appropriate course of action, which will serve the best interest of patients.