FDA Gives Tanezumab the Fast Track Status for Chronic LBP

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FDA Gives Tanezumab the Fast Track Status for Chronic LBP

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.

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.


Pain Medicine News

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FDA Gives Tanezumab Fast Track Status for Chronic LBP

Therapeutic, Tanezumab, lower back pain, lower back, global Phase 3 program, subcutaneously
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