Pfizer/Lilly Had Big Ambitions For Tanezumab; Are They Finally Dashed?

Mar 25 2021

• By Jessica Merrill

Listen to this article

Given serious safety questions with tanezumab, the US filing seemed like throwing a Hail Mary; two FDA advisory panels overwhelmingly rejected the proposed risk management plan.

Spiraling football in the sky — Pfizer hopes to get tanezumab to the end zone • Source: Shutterstock

Pfizer Inc. and Eli Lilly and Company have held out hope for approval of their first-in-class nerve growth inhibitor tanezumab in a substantial commercial market despite a serious risk profile that put the clinical trial program on hold and later led it to be scaled back. If tanezumab could win US Food and Drug Administration approval in osteoarthritis pain, where the risk appeared greatest, the companies believed label expansions could follow.

However, a near-term US approval of the biologics license application for osteoarthritis appears unlikely after the FDA's Arthritis Advisory Committee...

More from Neurological

Evidence Growing For GLP-1s To Treat Alzheimer’s And Parkinson’s
Mar 10 2025
• By Andrew McConaghie
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
As More DLL3 Bispecifics Advance, Doctors Are Adjusting To CRS, ICANS
Mar 10 2025
• By Mandy Jackson
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
Novo Nordisk’s Semaglutide Shows Promise In Hidradenitis Suppurativa
Mar 10 2025
• By Andrew McConaghie
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
Biogen Joins Molecular Glue Degrader Club with Neomorph Pact--Test-1
Dec 10 2024
• By Saba Afreen
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.

More from Therapeutic Category

Scrip Data Article Without An Author
Nov 19 2025
"Neque porro quisquam est qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit..."
Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]
Nov 12 2025
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC
Nov 12 2025
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.