MIV-711


Associated tags: Quality of life, Osteoclast, Cathepsin K, Necrosis, Cartilage, Joint, Osteoarthritis, Leg, Depression, Ageing, ODD, Patient, Obesity, Disease, FDA, Priority review, Sequela, Medivir, Hip, Cancer, Pharmaceutical industry

FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease

Retrieved on: 
Thursday, April 25, 2024
Leg, FDA, Cancer, Hip, Medivir, Sequela, Priority review, Risk, Osteoclast, Osteoarthritis, Partnership, Depression, Disease, Obesity, Patient, Cathepsin K, ODD, Ageing, Pharmaceutical industry

The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age.

Key Points: 
  • The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age.
  • Pediatric diseases recognized as "rare", affect fewer than 200,000 people in the United States.
  • We are delighted that MIV-711 has been granted RPDD by the FDA with the potential to become the first approved treatment option.
  • To gain RPDD, there must be supportive data suggesting that the drug may be effective in the disease.