A panel of experts from the US Food and Drug Administration has rejected Pfizer Inc. (NYSE: PFE) and Eli Lilly and company (NYSE: LLY) to approve its experimental drug for the treatment of osteoarthritis pain, citing safety risks and an inadequate plan to control them.
What happened: The FDA’s Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 1 that the risks of the drug Tanezumab outweigh its benefits for patients with moderate to severe osteoarthritis pain, Pfizer and Eli said. Lilly in a statement Thursday.
A single voting question focused on whether the proposed Risk Assessment and Mitigation Strategy (REMS) for tanezumab will ensure that its benefits outweigh its risks.
The Advisory Committee discussions were based on the Tanezumab Biologics License Application (BLA) which is currently under review by the FDA. The agency is not required to follow the committee’s recommendations, but generally does.
Pfizer is seeking FDA approval for 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 pain relievers is ineffective or inappropriate.
Pfizer said that while it was disappointed with the outcome, it will continue to work with the FDA as the agency continues to review the company’s application.
See also: Pfizer / Eli Lilly’s tanezumab safety profile fails to impress the FDA even after 15 years of development in 41 trials
Because it is important: Osteoarthritis is the most common type of arthritis, affecting approximately 31 million people in the US, 11 million of whom 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 began a collaboration to develop and commercialize tanezumab. If approved, the companies will jointly market tanezumab in the US and Pfizer will be responsible for marketing activities outside the US.
Price action: Pfizer shares closed about 0.2% higher Thursday at $ 35.67, while Eli Lilly shares closed 1.6% higher at $ 183.09.
Read next: In a key milestone, Pfizer begins testing the COVID-19 vaccine in children
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