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Tanezumab has been granted “fast track” status by FDA
for the treatment of chronic pain. After approval, it is expected to be the
first drug in the class of non-opioids chronic pain relievers.
Tanezumab is an investigational humanized monoclonal antibody, which exerts its effect by selectively targeting, binding to and inhibiting NGF. So it is a nerve growth factor (NGF) inhibitor.
Pfizer and Eli Lilly have announced that the Food and Drug Administration (FDA)
has granted the tanezumab, a Fast Track designation as a novel treatment for
chronic pain associated with chronic lower back pain and osteoarthritis.
Currently, a global Phase 3 program is studying the potential of Tanezumab.
This consists of 6 studies which have included around 7,000 patients. The
patient was suffering from osteoarthritis, chronic low back pain or cancer pain
and did not receive adequate treatment for pain with approved therapies. In
each study, subcutaneous injection of tanezumab will be administered by
healthcare providers on time in every eight weeks for treatment periods of 16
to 56 weeks, with a safety follow-up period of 24 weeks. This is done to
evaluate the efficacy of subcutaneous injection of tanezumab.
Tanezumab, a nerve growth factor (NGF) inhibitor and a first-in-class agent to
receive Fast Track approval. When NGF levels get elevated in inflammatory
conditions or chronic pain states, tanezumab will selectively bind and inhibit
the NGF. This enables to prevent the downstream spread of pain signals produced
by muscles, skin and organs to reach the brain and spinal cord.
If approved, tanezumab would be the first drug in a new class of non-opioid
agents for the management of chronic pain. Results of the study are expected to
be published in late 2018.
FDA
FDA Gives Tanezumab Fast Track Status for Chronic LBP
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