The NGF inhibitor class has claimed yet another victim. After seeing regulators on both sides of the Atlantic knock back filings for approval, Eli Lilly and Pfizer have stopped global clinical development of tanezumab.
INDIANAPOLIS, Oct. 26, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced financial results for the third quarter of 2021 today.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended nine medicines including Biogen’s Vumerity (diroximel fumarate) and Roche’s Gavreto (pralsetinib) for approval.
Pfizer and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.
U.S. FDA Accepts Regulatory Sub for Tanezumab, a Potential First-in-Class
Early into an important launch for Emgality and amid rollouts for other key meds, Eli Lilly Bio-Medicines chief Christi Shaw is stepping aside. She'll be replaced at the end of August by Lilly Japan chief Patrik Jonsson.
Safety setback for Pfizer, Lilly pain drug should have Regeneron and Teva feeling nervous
A lower dose of non-opioid painkiller developed by Pfizer Inc and Eli Lilly and Co failed to meet main goals in a late-stage study in patients with moderate-to-severe osteoarthritis of the hip or knee, the companies said on Thursday.
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. The tanezumab 5 mg treatment arm met two of the three co-primary efficacy endpoints, demonstrating a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs. Patients who received tanezumab 2.5 mg did not experience a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs. In the safety analysis, there was a higher rate of joint safety events in the tanezumab arms compared to NSAIDs at 80 weeks; the difference was statistically significant. Joint safety was a composite measure consisting of adjudicated outcomes of rapidly progressive osteoarthritis (RPOA) type 1 or type 2, subchondral insufficiency fracture, osteonecrosis or pathological fracture. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.