Pfizer: FDA questions REMS strategy for tanezumab
(CercleFinance.com) - Pfizer and Eli Lilly report that the US Food and Drug Administration (FDA) committees have found that the proposed Risk Evaluation and Mitigation Strategy (REMS) for tanezumab did not ensure that its benefits outweighed its risks, by a huge majority vote of 19 to 1.
The company is naturally disappointed with this outcome, although still believes that tanezumab has a positive benefit-risk profile for patients with moderate to severe osteoarthritis pain for whom current treatments are ineffective or inappropriate. It will continue to work with the FDA as the agency continues its review of its application.
Administered subcutaneously every eight weeks, the treatment is being evaluated for the treatment of moderate-to-severe osteoarthritis pain in adult patients for whom the use of other analgesics is ineffective or inappropriate.
In studies to date, tanezumab has not demonstrated any risk of dependence, misuse or addiction, Pfizer and Eli Lilly said.
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The company is naturally disappointed with this outcome, although still believes that tanezumab has a positive benefit-risk profile for patients with moderate to severe osteoarthritis pain for whom current treatments are ineffective or inappropriate. It will continue to work with the FDA as the agency continues its review of its application.
Administered subcutaneously every eight weeks, the treatment is being evaluated for the treatment of moderate-to-severe osteoarthritis pain in adult patients for whom the use of other analgesics is ineffective or inappropriate.
In studies to date, tanezumab has not demonstrated any risk of dependence, misuse or addiction, Pfizer and Eli Lilly said.
Copyright (c) 2021 CercleFinance.com. All rights reserved.