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Surprise! Pfizer And Lilly File Tanezumab For Pain With FDA Despite Safety Questions

 
• By Jessica Merrill

The partners have filed the first-in-class NGF inhibitor at the lower 2.5mg dose for the treatment of osteoarthritis pain, despite the drug’s challenging safety profile.

Surprise confetti
The prospects for tanezumab are uncertain • Source: Shutterstock

Pfizer Inc. and Eli Lilly & Co. have filed the first nerve growth factor (NGF) inhibitor, tanezumab, with the US Food and Drug Administration for the treatment of pain in patients with moderate-to-severe osteoarthritis. Pfizer confirmed the December filing during the company's fourth quarter sales and earnings call on 28 January.

The path to market for NGF inhibitors has been uncertain because of the challenging safety profile of the drugs, but Pfizer said it collaborated closely with the FDA on the filing. The regulatory filing was for the lower 2.5mg dose of tanezumab, which has shown modest efficacy and still had safety issues in clinical trials

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