An expert panel of the U.S. Food and Drug Administration has rejected Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company’s (NYSE: LLY) application to approve their experimental drug for the treatment of osteoarthritis pain, citing safety risks and an inadequate plan to manage them.
What Happened: The FDA’s Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19-1 that the drug Tanezumab’s risks outweigh its benefits for patients with moderate-to-severe osteoarthritis pain, Pfizer and Eli Lilly said in a statement Thursday.
A single voting question focused on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks.
The Advisory Committee’s discussions were based on Tanezumab’s Biologics License Application (BLA) currently under review by the FDA. The agency is not required to follow the recommendations of the committee, but it usually does.
Pfizer is seeking FDA approval of Tanezumab given by injection every two months for the treatment of moderate-to-severe osteoarthritis pain in adult patients for whom the use of other analgesics is ineffective or not appropriate.
Pfizer said that while it disappointed with the outcome, it will continue to work with the FDA as the agency continues its review of the company’s application.
See Also: Pfizer/Eli Lilly’s Tanezumab Safety Profile Fails To Impress FDA Even After 15 Years Of Development Across 41 Trials
Why It Matters: Osteoarthritis is the most common type of arthritis and impacts an estimated 31 million people in the U.S., of whom 11 million people have moderate-to-severe OA. Currently-available treatment options for moderate-to-severe OA do not meet the needs of all patients.
Tanezumab has been in development for more than 15 years. In 2013, Pfizer and Lilly entered into a collaboration to develop and commercialize tanezumab. If approved, the companies will jointly commercialize tanezumab in the U.S. and Pfizer will be responsible for commercialization activities outside of the U.S.
Price Action: Pfizer shares closed about 0.2% higher on Thursday at $35.67, while Eli Lilly shares closed 1.6% higher at $183.09.
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