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March 29, 2021/bioon.
com" target="_blank">/ - bioon.
com/tags/%E8%BE%89%E7%91%9E/">Pfizer (Pfizer) and bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Lilly (Eli Lilly) have jointly announced that the US Food and Drug Administration ( bioon.
com/fda/" target="_blank">the FDA ) Arthritis Joint Advisory Committee (JAAC) and Risk Management Advisory Committee and (DSRMAC) of monoclonal antibody drug safety class Results of the bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">conference on the painkiller tanezumab .
The meeting discussed the use of tanezumab (2.
5 mg, subcutaneously injected [SC], once every 8 weeks) for the treatment of moderate to severe osteoarthritis (OA) chronic pain.
bioon.com" target="_blank">/ - bioon.
com/tags/%E8%BE%89%E7%91%9E/">Pfizer (Pfizer) and bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Lilly (Eli Lilly) have jointly announced that the US Food and Drug Administration ( bioon.
com/fda/" target="_blank">the FDA ) Arthritis Joint Advisory Committee (JAAC) and Risk Management Advisory Committee and (DSRMAC) of monoclonal antibody drug safety class Results of the bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">conference on the painkiller tanezumab .
The meeting discussed the use of tanezumab (2.
5 mg, subcutaneously injected [SC], once every 8 weeks) for the treatment of moderate to severe osteoarthritis (OA) chronic pain.
com" target="_blank">bioon.
com/tags/%E8%BE%89%E7%91%9E/">Pfizer bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly bioon.
com/fda/" target="_blank">FDA bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">Meeting
There was a single voting question at this meeting, focusing on whether the proposed risk assessment and mitigation strategy (REMS) for tanezumab will ensure that its benefits outweigh the risks.
After discussion, the committee voted for 1 vote and 19 votes against.
It should be pointed out that the advisory committee provides independent opinions and recommendations from external medical experts to the bioon.
com/fda/" target="_blank">FDA during the regulatory review process , but these recommendations are not binding.
bioon. After discussion, the committee voted for 1 vote and 19 votes against.
It should be pointed out that the advisory committee provides independent opinions and recommendations from external medical experts to the bioon.
com/fda/" target="_blank">FDA during the regulatory review process , but these recommendations are not binding.
com/fda/" target="_blank">FDA
However, the FDA usually adopts the advisory committee's recommendations when making the final review decision.
This also means that tanezumab is highly likely to be rejected by the bioon.
com/fda/" target="_blank">FDA .
bioon. This also means that tanezumab is highly likely to be rejected by the bioon.
com/fda/" target="_blank">FDA .
com/fda/" target="_blank">FDA
Currently, tanezumab (2.
5 mg, subcutaneously injected [SC], once every 8 weeks) is being evaluated for treatment: patients with chronic pain caused by moderate to severe OA that are ineffective or unsuitable for other analgesics.
At present, OA treatment urgently needs innovation, because no new drugs have been used to treat this debilitating disease for more than ten years.
If approved, tanezumab will become a first-in-class therapy for patients who suffer from chronic pain due to moderate to severe OA and receive insufficient pain relief from other analgesics.
5 mg, subcutaneously injected [SC], once every 8 weeks) is being evaluated for treatment: patients with chronic pain caused by moderate to severe OA that are ineffective or unsuitable for other analgesics.
At present, OA treatment urgently needs innovation, because no new drugs have been used to treat this debilitating disease for more than ten years.
If approved, tanezumab will become a first-in-class therapy for patients who suffer from chronic pain due to moderate to severe OA and receive insufficient pain relief from other analgesics.
Osteoarthritis pain (picture source: mooreclinicalresearch.
com)
com)
Tanezumab is a humanized IgG2 monoclonal antibody that selectively targets and inhibits bioon.
com/tags/%E7%A5%9E%E7%BB%8F%E7%94%9F%E9%95%BF/">nerve growth factor (NGF).
When the body is injured, inflammation, or chronic pain, the level of NGF in the body will increase.
By selectively inhibiting NGF, tanezumab may help prevent pain signals generated by muscles, skin, or organs from reaching the spinal cord and brain.
bioon. com/tags/%E7%A5%9E%E7%BB%8F%E7%94%9F%E9%95%BF/">nerve growth factor (NGF).
When the body is injured, inflammation, or chronic pain, the level of NGF in the body will increase.
By selectively inhibiting NGF, tanezumab may help prevent pain signals generated by muscles, skin, or organs from reaching the spinal cord and brain.
com/tags/%E7%A5%9E%E7%BB%8F%E7%94%9F%E9%95%BF/">Nerve growth
Tanezumab is a new type of non-opioid pain reliever, classified as a bioon.
com/tags/%E7%A5%9E%E7%BB%8F%E7%94%9F%E9%95%BF/">nerve growth factor (NGF) inhibitor.
Tanezumab has a novel mechanism of action that is different from currently available opioids, non-steroidal anti-inflammatory drugs (NSAID) and other analgesics.
In the studies to date, tanezumab has not shown a risk of addiction, abuse or dependence.
bioon. com/tags/%E7%A5%9E%E7%BB%8F%E7%94%9F%E9%95%BF/">nerve growth factor (NGF) inhibitor.
Tanezumab has a novel mechanism of action that is different from currently available opioids, non-steroidal anti-inflammatory drugs (NSAID) and other analgesics.
In the studies to date, tanezumab has not shown a risk of addiction, abuse or dependence.
com/tags/%E7%A5%9E%E7%BB%8F%E7%94%9F%E9%95%BF/">Nerve growth
In the United States, more than 27 million people suffer from OA, of which 11 million suffer from moderate to severe OA.
At present, the available treatment options for moderate to severe OA cannot meet the needs of all patients.
Many patients find ways to relieve pain through a variety of treatment methods.
If approved, tanezumab has the potential to become the first NGF inhibitor analgesic for the treatment of OA pain.
At present, the available treatment options for moderate to severe OA cannot meet the needs of all patients.
Many patients find ways to relieve pain through a variety of treatment methods.
If approved, tanezumab has the potential to become the first NGF inhibitor analgesic for the treatment of OA pain.
Tanezumab was developed by Pfizer.
bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly and Pfizer signed an agreement of up to 1.
8 billion U.
S.
dollars in 2013 to promote the global joint development and commercialization of the drug.
In June 2017, the U.
S.
bioon.
com/fda/" target="_blank">FDA granted tanezumab fast track qualification for the treatment of osteoarthritis (OA) pain and chronic low back pain (CLBP).
Tanezumab is the first NGF inhibitor to qualify for fast track.
The drug has the potential to become a first-in-class drug for the treatment of OA pain and CLBP.
bioon. bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly and Pfizer signed an agreement of up to 1.
8 billion U.
S.
dollars in 2013 to promote the global joint development and commercialization of the drug.
In June 2017, the U.
S.
bioon.
com/fda/" target="_blank">FDA granted tanezumab fast track qualification for the treatment of osteoarthritis (OA) pain and chronic low back pain (CLBP).
Tanezumab is the first NGF inhibitor to qualify for fast track.
The drug has the potential to become a first-in-class drug for the treatment of OA pain and CLBP.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly bioon.
com/fda/" target="_blank">FDA
Tanezumab: or become the first NGF inhibitor pain reliever
Tanezumab: or become the first NGF inhibitor pain relieverNerve growth factor (NGF) regulates pain signals into the central nervous system
The discussion of the advisory committee is based on the biological product licensing application (BLA) currently being reviewed by the US bioon.
com/fda/" target="_blank">FDA .
The BLA includes data from 20 phase 1-3 clinical studies involving more than 18,000 patients, evaluating intravenous (IV) or subcutaneous injections (SC) The safety and effectiveness of tanezumab in the treatment of OA patients, including 3 key phase 3 subcutaneous injection (SC) studies, involving more than 4500 patients with moderate to severe OA.
bioon. com/fda/" target="_blank">FDA .
The BLA includes data from 20 phase 1-3 clinical studies involving more than 18,000 patients, evaluating intravenous (IV) or subcutaneous injections (SC) The safety and effectiveness of tanezumab in the treatment of OA patients, including 3 key phase 3 subcutaneous injection (SC) studies, involving more than 4500 patients with moderate to severe OA.
com/fda/" target="_blank">FDA
Osteoarthritis (OA) is a chronic, progressive and disabling joint disease, which is the main cause of chronic pain.
In the United States, an estimated 31 million people are affected by OA, of which 11 million suffer from moderate to severe OA, with an average disease lasting 9 years.
OA puts a heavy burden on these patients-pain limits their functions, which forces them to make compromises in their daily lives, negatively affects their roles and relationships, and leads to feelings of loneliness, depression and anxiety .
OA will also affect their ability to work in the workplace.
There is an urgent need for innovation, because the current treatment options available for moderate to severe OA cannot meet the needs of all patients.
In the United States, an estimated 31 million people are affected by OA, of which 11 million suffer from moderate to severe OA, with an average disease lasting 9 years.
OA puts a heavy burden on these patients-pain limits their functions, which forces them to make compromises in their daily lives, negatively affects their roles and relationships, and leads to feelings of loneliness, depression and anxiety .
OA will also affect their ability to work in the workplace.
There is an urgent need for innovation, because the current treatment options available for moderate to severe OA cannot meet the needs of all patients.
Ken Verburg, head of the tanezumab development team at Pfizer’s global product development division, said: “Although we are disappointed with today’s results, we still believe that tanezumab has positive benefits for patients with moderate to severe osteoarthritis pain who are currently ineffective or inappropriate.
-Risk characteristics.
Many of these patients have exhausted the available treatments, no new drugs are available for them for more than a decade, and are eager for new non-opioid treatment options.
We will continue to review at the bioon.
com/fda/" target="_blank">FDA During the BLA process, work closely with the agency.
"
bioon. -Risk characteristics.
Many of these patients have exhausted the available treatments, no new drugs are available for them for more than a decade, and are eager for new non-opioid treatment options.
We will continue to review at the bioon.
com/fda/" target="_blank">FDA During the BLA process, work closely with the agency.
"
com/fda/" target="_blank">FDA
bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Ilya Yuffa, President of bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly Biopharmaceuticals, said: “The dialogue during the public forum of the advisory committee meeting this week reinforces the urgent need for innovation in patients with moderate to severe osteoarthritis pain.
Many of them receive 3-4 treatments every year.
But they have not received enough pain relief.
Unresolved pain will affect all aspects of their lives and cause physical, emotional, social and economic difficulties.
" ()
bioon. com/tags/%E7%A4%BC%E6%9D%A5/">Ilya Yuffa, President of bioon.
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly Biopharmaceuticals, said: “The dialogue during the public forum of the advisory committee meeting this week reinforces the urgent need for innovation in patients with moderate to severe osteoarthritis pain.
Many of them receive 3-4 treatments every year.
But they have not received enough pain relief.
Unresolved pain will affect all aspects of their lives and cause physical, emotional, social and economic difficulties.
" ()
com/tags/%E7%A4%BC%E6%9D%A5/">Eli Lilly ()
Original source: Joint bioon.
com/fda/" target="_blank">FDA Advisory Committee Votes on app lication for Tanezumab for the Treatment of Osteoarthritis Pain
bioon. com/fda/" target="_blank">FDA Advisory Committee Votes on app lication for Tanezumab for the Treatment of Osteoarthritis Pain
com/fda/" target="_blank">FDA app
