Once blocked again, can Pfizer and Eli Lilly’s osteoarthritis painkiller Tanezumab usher in the dawn?

On March 25, local time, Pfizer and Eli Lilly and Company jointly announced that due to its osteoarthritis (OA) painkiller tanezumab, which may pose a major safety risk, the U.
S.
Food and Drug Administration ( FDA) Arthritis Joint Advisory Committee and Drug Safety and Risk Management Advisory Committee ultimately rejected the drug's marketing application with 1 vote in favor and 19 votes against.

Osteoarthritis is the most common form of arthritis.
It is a non-inflammatory degenerative joint disease.
In the United States, approximately 20 million patients suffer from pain caused by this for a long time.

According to statistics from the World Health Organization, the incidence of osteoarthritis is 50% among people over 50 years old, and 80% among people over 55 years old.

Tanezumab, as an alternative therapy to non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, is a humanized lgG2 monoclonal antibody that can specifically target nerve growth factor (NGF) and block muscles by selectively inhibiting NGF The pain signals from the skin or organs reach the spinal cord and brain.

So far, the development of Tanezumab has spanned 15 years.
A total of 41 clinical studies, 38 interventional trials and 3 observational studies have been conducted, and nearly 18,000 patients have been recruited.

In 2004, Pfizer first submitted an investigational new drug application for Tanezumab, but it was frustrated in the Phase III clinical trial in 2010.
After receiving Tanezumab treatment, the patient experienced increased joint damage speed and other non-targeted joint bones.
For symptoms of joint necrosis, the U.
S.
Food and Drug Administration (FDA) quickly halted all Anti-NGF antibody clinical trials, including Tranezumab.

Two years later, Pfizer restarted the phase III clinical trial of Tanezumab, but it was stopped again due to possible side effects on sympathetic neuron damage in the preclinical model.

However, Pfizer was not discouraged and decided to sign a $1.
8 billion agreement with Eli Lilly to continue to promote the global joint development and commercialization of the drug.

In 2015, after cooperating with the U.
S.
Food and Drug Administration (FDA), Pfizer reopened the Phase III clinical trial of Tanezumab.

In 2017, the U.
S.
Food and Drug Administration (FDA) granted Tanezumab fast track qualification for the treatment of osteoarthritis (OA) pain and chronic low back pain (CLBP), making it the first NGF inhibitor to obtain fast track qualification.

In 2020, Pfizer and Eli Lilly announced that the Phase III clinical results of Tanezumab showed that the drug has achieved consistent efficacy in relieving pain and improving physical function.

However, its dosage may increase the incidence of adverse events.

Although the road to market for Tanezumab is long and tortuous, the dawn has already begun.
For patients with severe osteoarthritis, tanezumab still has positive benefits and risks.

So far, the drug has not suffered from negative problems such as drug dependence.

Therefore, Pfizer and Eli Lilly will continue to cooperate with the US Food and Drug Administration (FDA) review, hoping that Tanezumab will live up to expectations and usher in the light of twists and turns.

End reference materials: [1] m.
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[3] -unanimous-vote