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Eli Lilly: Tanezumab 10 Mg Meets Primary Endpoint In Phase 3 Study - Quick Facts

Pfizer Inc. (PFE) and Eli Lilly and Company (LLY) announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain. In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo.

The tanezumab 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis.

Ken Verburg, tanezumab development team leader, Pfizer Global Product Development, said: "This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain."

In 2013, Pfizer and Lilly entered into a worldwide co-development and co-commercialization agreement for the advancement of tanezumab. In June 2017, Pfizer and Lilly announced the U.S. FDA granted Fast Track designation for tanezumab for the treatment of osteoarthritis pain and chronic low back pain.

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