Ministry of Health (Kuwait)

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

Retrieved on: 
Tuesday, April 4, 2023
Priority review, Plaque, CET, MHLW, Marketing, Advisory Committee, Memantine, Food, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Clinical trial, Quality of life, Ministry of Health, Labour and Welfare, Brain, Alzheimer's disease, SOC, MCI, Medication, Pharmaceuticals and Medical Devices Agency, Advisory Committee on Immunization Practices, EMA, Clarity, Ministry, Eisai, Prescription Drug User Fee Act, HIV disease progression rates, Patient, Standard of care, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), Neurology, MAA, AD, FDA, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Caregiver, Safety, Pharmaceutical industry, Biogen, Health

A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

Retrieved on: 
Tuesday, April 4, 2023
Priority review, Plaque, CET, MHLW, Marketing, Advisory Committee, Memantine, Food, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Clinical trial, Quality of life, Ministry of Health, Labour and Welfare, Brain, Alzheimer's disease, SOC, MCI, Medication, Pharmaceuticals and Medical Devices Agency, Advisory Committee on Immunization Practices, EMA, Clarity, Ministry, Eisai, Prescription Drug User Fee Act, HIV disease progression rates, Patient, Standard of care, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), Neurology, MAA, AD, FDA, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Caregiver, Safety, Pharmaceutical industry, Biogen, Health

A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Darolutamide receives approval for additional prostate cancer indication in Japan

Retrieved on: 
Monday, February 27, 2023
CHMP, Death, Ministry of Health (Kuwait), Ministry, Prostate cancer, The New England Journal of Medicine, Disease, Ari, Risk, Darolutamide, Patient, ADT, Orion, Docetaxel, University of Medicine 1, Yangon, Indoor Living, European Directive on Traditional Herbal Medicinal Products, Incidence, Phase, MHLW, Pharmaceutical industry, Health, Bayer, EU

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.

Key Points: 
  • The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to evauate its potential across prostate cancer patients from the early- to the late-stage of this disease.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.