Osteoarthritis pain (Image source: mooreclinicalresearch.com)
September 18, 2021 News /
BioonBIOON/ --The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recently issued an assessment opinion,
Recommendation to deny approvalNovel Analgesic Raylumis (tanezumab) for the Treatment of Chronic Pain in Adults with Moderate to Severe Osteoarthritis (OA)， specifically for: moderate to severe pain associated with osteoarthritis (OA) of the hip or knee in patients who have had an inadequate response to, or are unsuitable for, nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids.
Following review, the CHMP considered that,Although tanezumab demonstrated greater pain relief and improvement in physical function compared with placebo in patients with hip or knee osteoarthritis, the differences were small.. In addition,Compared with nonsteroidal anti-inflammatory drugs (NSAIDs), tanezumab showed no difference in pain relief and improvement in physical function.. justIn terms of safety, compared with patients receiving placebo or NSAIDs, those treated with tanezumab had an increased risk of adverse events, such as rapidly progressive osteoarthritis and joint replacement surgery.
Therefore, the CHMP's opinion is that,The benefit of tanezumab in patients with an inadequate response to NSAIDs or opioids remains unclear and does not outweigh its risks; therefore, refusal of marketing authorization is recommended.
Raylumis by
`Pfizer`(Pfizer) and
Eli Lilly(Eli Lilly) co-developed, as a subcutaneous injection therapy (2.5 mg, administered once every 8 weeks), for the treatment of: patients with chronic pain caused by moderate to severe OA who have had an inadequate response to or are unsuitable for other analgesic therapies. There is a pressing need for innovation in current OA treatments, as no new drugs have been approved to treat this debilitating disease in over a decade. For patients suffering from chronic pain due to moderate to severe OA who experience insufficient pain relief from other analgesics, tanezumab has the potential to become a first-in-class therapy.
It is worth mentioning that in March this year,
United StatesFDAJoint Arthritis Advisory Committee (JAAC) and Drug Safety and Risk Management Advisory Committee (DSRMAC) ConveneMeeting， overwhelmingly rejected the application for tanezumab (2.5 mg, subcutaneous injection [SC], once every 8 weeks) for the treatment of chronic pain in moderate to severe osteoarthritis (OA).At this meeting, a single voting question focused on whether the proposed Risk Evaluation and Mitigation Strategy (REMS) for tanezumab would ensure that its benefits outweigh its risks. Following discussion, the committee voted 1 in favor and 19 against.
Nerve GrowthFactor (NGF) Regulates Pain Signals Entering the Central Nervous System
Osteoarthritis (OA) is a chronic, progressive, and debilitating joint disease and a leading cause of chronic pain. OA imposes a substantial burden on patients—pain limits their physical function, forcing them to make compromises in their daily lives, adversely affecting their roles and relationships, and leading to feelings of loneliness, depression, and anxiety. OA also impairs their work capacity. There is an urgent need for innovation, as currently available treatment options for moderate to severe OA fail to meet the needs of all patients.
tanezumab is a humanized IgG2 monoclonal antibody that selectively targets, binds to, and inhibits
Nerve GrowthFactor (NGF) exerts its effect. In conditions of injury, inflammation, or chronic pain, NGF levels in the body increase. By selectively inhibiting NGF, tanezumab may help prevent pain signals originating from muscles, skin, or organs from reaching the spinal cord and brain.
Tanezumab is a novel non-opioid analgesic classified as a nerve growth factor (NGF) inhibitor. Tanezumab features a novel mechanism of action distinct from currently available opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and other analgesics.In studies to date, tanezumab has not demonstrated a risk of addiction, abuse, or dependence.
Currently, available treatment options for moderate-to-severe OA do not adequately meet the needs of all patients, with many seeking pain relief through multiple therapeutic modalities.If approved, tanezumab has the potential to become the first NGF inhibitor-class analgesic for the treatment of OA pain.
Tanezumab was developed by Pfizer,
Eli LillyIn 2013, an agreement worth up to $1.8 billion was signed with Pfizer to advance the global co-development and commercialization of the drug. In June 2017, the United States
FDAFast Track designation has been granted to tanezumab for the treatment of osteoarthritis (OA) pain and chronic lower back pain (CLBP). Tanezumab is the first NGF inhibitor to receive Fast Track designation. The drug has the potential to become a first-in-class therapy for OA pain and CLBP. (Bioon.com)
