The FDA accepts Pfizer/Lilly's potential "first-in-class" painkiller listing application.

OA, an Advanced joint disease caused by the wear of protective cartilage at both ends of the bone. One of the most important symptoms of
OA is chronic pain, which can occur during or after joint movement, and also limits the patient's ability to exercise.
in the United States, OA affects about 27 million people, of whom 11 million are moderate to severe OA patients.
these OA patients are in desperate need of a new, safe treatment to help them manage their pain.
Tanezumab is a humanized neurogrowth factor monoclonal antibody and the first NGF inhibitor qualified by the FDA for fast-track, which has the function of selective binding and inhibiting NGF.
levels of NGF increase in the event of pain or chronic pain caused by injury, inflammation, or chronic pain in the body.
, therefore, by selectively suppressing NGF, tanezumab may help block pain signals generated by muscles, skin and organs into the spinal cord and brain.
, since the new mechanism of tanezumab is completely different from opioids and other analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), there has never been any risk of addiction, abuse or dependence in trials to date.
Tanezumab's research currently focuses on the treatment of OA pain, severe chronic back pain (CLBP), and pain caused by cancer bone metastasis. the mechanism of action of the
Tanezumab (Photo Source: References) The BLA was submitted based on positive data from 39 Phase 1 to 3 clinical trials that evaluated the efficacy and safety of tanzumaeb in the treatment of 18,000 patients, including 3 phase 3 trials for patients with moderate to severe OA.
in one of the 24-week Phase 3 clinical studies, tanezumab reached all the end points of the trial, which resulted in a statistically significant improvement in pain and physical function in patients with moderate or severe OA pain in the knee or hip.
in another 16-week, phase 3 clinical study, more than half of patients received a 50 percent or more reduction in pain.
"The FDA's acceptance of tanezumab's listing is an important milestone," said Dr. Ken Verburg, head of Pfizer's global product development team.
therefore, these patients urgently need innovative therapies.
other painkillers did not provide good relief to the treatment of chronic pain caused by moderate to severe OA.
if approved, tanezumab will be the first-in-class therapy for these patients.
" OA patients face a huge burden of physical pain, affecting almost every aspect of their lives.
this pain affects their ability to participate in daily activities and has a significant impact on patient psychology," said Patrik Johnson, president of Lilly Biomedical, "we look forward to working closely with the FDA to bring tanezumab to patients with moderate and severe OA as soon as possible."
" References: U.S. FDA S. Fda Regulatory Submission for Tanezumab, A Potential First-in-Class For Patients Chronic Chronic Pain Due to Moderate-to-Severe Ostearthritis V, Retrieved March 03, 2020, from .2. Retrieved March, 03, 2020, from the courier. Pfizer/Lilly Osteoarthritis in research has reached the end of all phase 3s. Retrieved March, 03, 2020, from the 4. Significant relief of osteoarthritis pain, Pfizer/ Lilly in the study of painkillers in the third phase of positive results. Retrieved March, 03, 2020, from .5. More than half of patients reduced pain by more than 50%, and the results of the innovative painkiller phase 3 were encouraging. Retrieved March, 03, 2020, from the original title: Express. The FDA accepts Pfizer/Lilly's potential "first-in-class" painkiller listing application for osteoarthritis patients.