Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2455 |
| INN | Tanezumab |
| Status | Terminated |
| Drug code(s) | RN624, RI-624, PF-04383119 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | NGF |
| Indications of clinical studies | Pain (osteoarthritis, post-surgical, chronic) |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Terminated at regulatory review |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2004 |
| Start of Phase 2 | April 15, 2006 |
| Start of Phase 3 | September 16, 2015 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Pfizer, Rinat |
| Licensee/Partner | Eli Lilly |
| Comments about company or candidate | In October 2021, Pfizer and Eli Lilly and Company discontinued the global clinical development program for tanezumab, an investigational nerve growth factor (NGF) inhibitor. This decision was made following receipt of a Complete Response Letter (CRL) from the FDA for the tanezumab application in osteoarthritis (OA) and a negative opinion adopted by the EMA’s CHMP on the tanezumab marketing authorization application in OA. At a meeting held September 13-16, 2021, EMA’s CHMP recommended the refusal of a marketing authorization for tanezumab for the treatment of pain associated with osteoarthritis. March 26, 2021: The FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 19 to one that while clinical data indicates tanezumab can benefit patients, the associated risk for joint destruction or rapidly progressive osteoarthritis (RPOA) was too great. Pfizer is currently seeking US approval for the drug, an investigational nerve growth factor (NGF) inhibitor, as a non-opioid treatment for moderate-to-severe OA pain in adults for whom the use of other analgesics is ineffective or inappropriate. From Lilly Q1 2021 results: In the first quarter of 2021 an Advisory Committee to the FDA concluded that the proposed risk evaluation and mitigation strategy will not ensure that the benefits outweigh the risks. In collaboration with Pfizer, we plan to continue to work with the FDA as it continues to review the submission. March 2, 2020: The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the tanezumab application is in December 2020. In its acceptance letter, the FDA stated that it is currently planning to hold an Advisory Committee meeting to discuss this application. Company Q4 Earnings Conference Call 01/28/2020: Pfizer announced that it completed the U.S. submission for tanezumab in December 2019. This submission was done in close collaboration with the FDA, and it includes the 2.5 mg dose in moderate-to-severe osteoarthritis patients. Based on a standard 12-month original BLA filing under PDUFA VI guidelines, the PDUFA decision should occur in December 2020. July 2019: Based on an assessment of the totality of subcutaneous (SC) tanezumab data and an initial discussion with the FDA during second-quarter 2019, Pfizer and Eli Lilly and Company (Lilly) have decided to pursue a U.S. regulatory submission for tanezumab 2.5 mg SC in patients with moderate-to-severe osteoarthritis (OA) that is expected to be filed with the FDA in fourth-quarter 2019 or early 2020, to be followed by potential regulatory filings in the EU and Japan (https://s21.q4cdn.com/317678438/files/doc_financials/Quarterly/2019/q2/Q2-2019-PFE-Earnings-Release.pdf). Jan 2019: Pfizer Inc. (PFE) and Eli Lilly and Company (LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain. The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA compared to those receiving placebo. The tanezumab 2.5 mg treatment arm met two of the three protocol-defined co-primary efficacy endpoints compared to placebo, demonstrating a statistically significant improvement in pain and physical function, while patients’ overall assessment of their OA was not statistically different than placebo. NCT02609828 Phase 3 study still recruiting as of Aug 2018. June 2017: Pfizer and Eli Lilly and Co.'s humanized monoclonal antibody tanezumab has been granted Fast-track designation by the FDA as a treatment for chronic pain in patients with chronic back pain and osteoarthritis. NCT02528188 and NCT02528253 Phase 3 studies for pain in subjects with osteoarthritis of the hips or knees and chronic low back pain, respectively, started in Sep 2015. Phase 3 to start in 2014 as per Pfizer Earnings call July 30, 2013. Development was suspended in 2010; FDA lifted clinical hold in 2012; listed in Pfizer pipeline as Phase 2 for cancer pain. As of Oct 2013, Pfizer has partnered with Lilly, but the tanezumab program currently is subject to a partial clinical hold by the FDA pending submission of nonclinical data to the FDA. In March 2015, U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015. |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
A330S, P331S mutations decrease effector functions; hIgG2Δa
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Safety issues |