The patients have multiple other options that can be equal to inefficiency, and a new drug that contains risks must hold better efficiency.
The advisory committees of the FDA have rejected the risk mitigations from Pfizer for the tanezumab NGF blocker. They stated that it fails to ensure the benefits of the drug outweigh the risks associated with it for osteoarthritis patients.
"The point that we are currently tussling is the risk evaluation as well as the mitigation of the strategy program, which in my opinion, is very accurate," added the member of the University of Minnesota, Cheng.
It has been said that Pfizer is seeking the approval of the tanezumab for the relief of the symptoms along with the signs of moderate to even severe OA found in adults for whom the rest analgesics were found to be ineffective or even non-appropriate.
The REMS approval of the Pfizer included the limitation of the dose to 2.5 mg and the baseline along with the X-ray of the patient's knees and hips, the education prescriber, excluding the patients that have other types of preexisting diseases related to joints, and even the limitation of the drugs to the ones who have more severe OA which is unresponsive to the available analgesics.
According to consumer representative Suzanne B. Robotti, the risks are not yet apparent. She added that the patients have multiple other options that can be equal to inefficiency, and a new drug that contains risks must hold better efficiency.
It was stated that the tanezumab has one severe risk, and it is rapidly progressive, which can necessitate the joint replacement as a whole.
It should be noted that the tanezumab is not meant for patients who have OA pain, and it should not be used as a replacement for NSAIDs. The main focus here is avoiding putting the patients on opioids as much as possible.
Pfizer successfully provided substantial evidence of the efficiency related to the tanezumab, and it was called the modest treatment effect size available.
Verburg stated that if tanezumab gets approved, it will be the new pharmacologic class when it comes to pain therapy. It will be the mechanism of the action that is very distinct from the opioids and the NSAIDs, and it is devoid of addiction, abuse, and even overdose, and even some other serious concerns related to safety that are associated with the use of the opioid and the NSAID.
During a joint meeting, it was stated that the risk associated with the tanezumab is the destruction of the joints, and it has led to total joint replacement in some patients after a year of the treatment.
It was also added that the tanezumab is associated with the risk of the joint replacement is increased along with the dose-response evidence collected. According to the FDA analyses, the ratio of the hazards caused for the total; joint replacement is accounted for approximately two for the 2.5 mg dose of tanezumab. On the other hand, the hazard ratio that surpasses three for the doses is above 2.5 mg.
Reference: healio.com
