Pfizer and Lilly Report Unfavorable FDA Advisory Panel Vote for Tanezumab -- Update

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By Josh Beckerman

Pfizer Inc. and Eli Lilly & Co. announced an unfavorable vote from a joint Food and Drug Administration advisory committee on tanezumab for osteoarthritis pain.

The companies said the vote was one in favor and 19 against on the single voting question focused on whether the proposed risk evaluation and mitigation strategy will ensure benefits outweigh risks.

Pfizer and Lilly said that "while we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate."

An FDA briefing document posted this week said "the review team has concluded that the tanezumab development program provides substantial evidence of effectiveness. However, the treatment effect size is modest, and there is no convincing evidence of a superior efficacy of tanezumab over NSAIDs."

In June 2010, Pfizer suspended the osteoarthritis clinical program for tanezumab following a small number of reports of patients experiencing the worsening of osteoarthritis, leading to joint replacement. In 2013, Pfizer and Lilly entered a world-wide co-development and co-commercialization agreement for the drug, which in 2017 was granted Fast Track designation by the FDA.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

March 25, 2021 18:37 ET (22:37 GMT)

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