The data were presented at the 63rd
While the treatment and management of severe hemophilia A is being established, there is less information and treatment guidance on moderate and mild hemophilia A, which can lead to delayed or missed diagnosis of bleeding episodes.2 Considering this population may not use preventative treatments, they may experience worsened clinical burden, with less than 30% of people with moderate or mild hemophilia A living a bleed-free life.2,3
'I am delighted that further data confirmed Hemlibra's potential benefits in treatment of moderate and mild hemophilia A, in which there are still high unmet medical needs in the world,' said Chugai's President and CEO, Dr.
HAVEN 6 is a phase III study evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of Hemlibra in people with moderate or mild hemophilia A without factor VIII inhibitors. This interim analysis included data from 71 participants (69 men and two women); 20 of whom had mild hemophilia A without factor VIII Inhibitors and 51 had moderate hemophilia A without inhibitors. 37 participants were on factor VIII prophylaxis at baseline.1
This interim analysis was conducted after 50 participants with moderate hemophilia A completed at least 24 weeks in the study or withdrew. Data cut-off was on
The most common adverse events (AEs) occurring in 10% or more people in the HAVEN 6 study were headache (14.1%) and local injection site reactions (ISRs) (12.7%). Eleven people (15.5%) reported a Hemlibra-related AE, with ISRs being the most common (12.7%).
Hemlibra is approved to treat people with hemophilia A with factor VIII inhibitors in more than 100 countries worldwide and for people without factor VIII inhibitors in more than 90 countries worldwide, including the US, EU and
About Hemlibra
Hemlibra is a bispecific monoclonal antibody created with Chugai's proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII4,5. The product was approved by the
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
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