Tanezumab (
INN
Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they also provided accommo ...
, codenamed RN624) is a
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodies ...
against
nerve growth factor as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs. Tanezumab was discovered and developed by
Rinat Neuroscience and was acquired by
Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
in 2006.
In 2009 there was a
Phase III trial for knee pain due to
osteoarthritis (OA).
Another Phase III trial for hip pain in OA was halted in June 2010 when some patients needed hip replacement.
Tanezumab is undergoing
Phase II clinical trials for the treatment of various pain entities, including chronic low back pain,
bone cancer pain, and
interstitial cystitis
Interstitial cystitis (IC), a type of bladder pain syndrome (BPS), is chronic pain in the bladder and pelvic floor of unknown cause. It is the urologic chronic pelvic pain syndrome of women. Symptoms include feeling the need to urinate right aw ...
.
In March 2012, the Anti-NGF Testing - FDA Committee voted in favor of a continuation of the development of nerve-blocking medications, as long as certain safety precautions were observed.
A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.
At February 19, 2019 the co-development partners - Eli Lilly and Pfizer - announced that treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in chronic low back pain at 16 weeks compared to placebo (however, 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis).
Society and culture
Legal status
On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for tanezumab (Raylumis), a medicine intended for the treatment of pain associated with osteoarthritis.
On 25 March 2021, the FDA Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 1 to 19 against the question : on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks.
See also
*
List of investigational analgesics
This is a list of investigational analgesics, or analgesics that are currently under development for clinical use but are not yet approved. ''Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in pare ...
References
External links
All registered trials involving Tanezumab
Analgesics
Monoclonal antibodies
Pfizer brands
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