Delamanid

CHMP grants positive opinion in the European Union for Otsuka’s child-friendly 25 mg dispersible tablet formulation of Deltyba® (delamanid) for the paediatric population weighing at least 10 kg with pulmonary multi-drug resistant tuberculosis

Retrieved on: 
Monday, July 26, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Medical Supplies, Otsuka Pharmaceutical, Companies, Delamanid, Economy of Japan, Taiho Pharmaceutical, Deltyba (delamanid), MDR/RR-TB, Otsuka Novel Products GmbH, DELTYBA (DELAMANID), MDR/RR-TB, OTSUKA NOVEL PRODUCTS GMBH

Previously, there were almost no treatment options available for this group of children.

Key Points: 
  • Previously, there were almost no treatment options available for this group of children.
  • Safety and tolerability data from the two paediatric trials were in line with the known safety and tolerability profile of delamanid in the adult population.
  • ONPG is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.
  • Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide.

CHMP Grants Positive Opinion for Expanded Use of Otsuka’s Deltyba® (delamanid) in Children and Adolescents Weighing at Least 30kg Treated for Pulmonary Multi-drug Resistant Tuberculosis

Retrieved on: 
Monday, September 21, 2020
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Infectious diseases, Health, Otsuka Pharmaceutical, Delamanid, Tuberculosis, Deltyba® (delamanid), MDR/RR-TB, Otsuka Novel Products GmbH

We look forward to working with the TB community to further enhance access of delamanid in this age group.

Key Points: 
  • We look forward to working with the TB community to further enhance access of delamanid in this age group.
  • Thirteen patients were enrolled in Trial 232: 7 in Group 1 (12 17 years) and 6 in Group 2 (6 11 years).
  • ONPG is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.
  • June 2020, Available at: https://accesstomedicinefoundation.org/media/uploads/downloads/5ee1fd19b... (Last accessed: September 2020)
    11Ignatius E. and Dooley K. New Drugs for the Treatment of Tuberculosis Clin Chest Med.