Chugai News Releases are issued to provide stakeholders with the most up-to-date information related to our company. In some instances, information on products or drug candidates under development may be included, but this is intended for members of the media, shareholders, and investors. The information is not intended for promotional or advertising purposes, or as medical advice, etc.

Oct 18, 2019

Data on the use of Chugai’s Hemlibra in Hemophilia A Children with or without Inhibitors were Published in Journals

  • Data from a Japanese clinical study HOHOEMI conducted by Chugai with hemophilia A children without inhibitors were published in Haemophilia online
  • Data from a global clinical study HAVEN 2 conducted with hemophilia A children with inhibitors were published in Blood online

TOKYO, October 18, 2019 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that two data on the use of Chugai’s hemophilia A treatment Hemlibra® (emicizumab) in children were published in journals.

“Conventional standard treatment for hemophilia A requires intravenous injections multiple times a week, which can be a treatment hurdle especially for children with difficult vascular access. Hemlibra can be administered subcutaneously in a longer dosing interval. We are very pleased that data on the use of Hemlibra in children were published in the international journals,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “The HOHOEMI study that we conducted in Japan is the first clinical study which examined the use of Hemlibra in hemophilia A children without inhibitors. We will continue undertaking clinical studies with exceptional science so that patients and healthcare professionals may use Chugai’s products with more confidence.”

[Overview of publication]

  1. HOHOEMI study: a Japanese phase III study conducted by Chugai

  • Journal: Haemophilia online (published on September 12, 2019)
  • Title: A multicentre, open‐label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors
  • URL: https://doi.org/10.1111/hae.13848
  • Overview of the study:
    • A Japanese study investigating the efficacy, safety and pharmacokinetics of once every two weeks or every four weeks subcutaneous administration of Hemlibra prophylaxis in children with hemophilia A without inhibitors including infants previously untreated with FVIII therapy.
    • Annualized bleeding rates for treated bleeding events (95% CI) were 1.3 (0.6; 2.9) in those receiving Hemlibra every two weeks (n=6), and 0.7 (0.2; 2.6) in those receiving Hemlibra every four weeks (n=7).
    • The most frequently reported adverse events were contusion (76.9%), nasopharyngitis (38.5%), and excoriation and fall (30.8%).

  2. HAVEN 2 study: a global phase III study

  • Journal: Blood online(published on October 10, 2019)
  • Title: A multicenter, open-label, phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors
  • URL: https://doi.org/10.1182/blood.2019001869
  • Overview of the study:
    • A global study evaluating the efficacy, safety and pharmacokinetics of once weekly, every two weeks or every four weeks subcutaneous administration of Hemlibra prophylaxis in children with hemophilia A with factor VIII inhibitors.
    • Annualized bleeding rates for treated bleeding events (95% CI) were 0.3 (0.17; 0.50) in those receiving Hemlibra once weekly (n=65), 0.2 (0.03; 1.72) in those receiving Hemlibra every two weeks (n=10) and 2.2 (0.69; 6.81) in those receiving Hemlibra every four weeks (n=10).
    • The most common adverse events in enrolled 88 children were nasopharyngitis (37.5%) and injection site reactions (29.5%).

Trademarks used or mentioned in this release are protected by law.

Contact:

  • For Media
  • Chugai Pharmaceutical Co., Ltd.
  • Media Relations Group, Corporate Communications Dept.,
  • Tomoko Shimizu
  • Tel: +81-3-3273-0881
  • E-mail: pr@chugai-pharm.co.jp
  • For Investors
  • Chugai Pharmaceutical Co., Ltd.
  • Investor Relations Group, Corporate Communications Dept.,
  • Toshiya Sasai
  • Tel: +81-3-3273-0554
  • E-mail: ir@chugai-pharm.co.jp
  • Like
  • Tweet
  • LINE it!
  • E-mail
Back to top