Date: 2017-12-07
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at The American Society of Hematology (ASH) 2017
Company: Roche (Switzerland)
Product: emicizumab (ACE910 - anti-factor IXa x anti-factor X humanized bispecific antibody)
Action
mechanism:
- bispecific antibody. Emicizumab is a bispecific antibody that mimics coagulation factor VIII. It is currently investigated as a therapy for people with hemophilia A. Emicizumab was designated as a Breakthrough Therapy by the FDA in September 2015.
Disease: hemophilia A
Therapeutic
area: Rare diseases - Genetic diseases - Hematological diseases
Country: Australia, Belgium, Japan, Poland, Spain, USA
Trial
details:
- HAVEN 4 is a multicenter, open-label, phase III study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) in patients with hemophilia A. The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part. (NCT03020160)
Latest
news:
- • On December 7, 2017, Roche announced positive interim results from the phase III HAVEN 4 study evaluating Hemlibra® (emicizumab) prophylaxis dosed once every four weeks in adults and adolescents (12 years of age or older) with haemophilia A with and without inhibitors to factor VIII. At this interim analysis after a median of 17 weeks of treatment, Hemlibra® prophylaxis showed a clinically meaningful control of bleeding. These results are consistent with previous studies of Hemlibra® dosed once weekly or every two weeks, including the pivotal studies in haemophilia A with inhibitors, HAVEN 1 in adults and adolescents and HAVEN 2 in children, as well as the phase III HAVEN 3 study in adults and adolescents with haemophilia A without inhibitors. The most common adverse events with Hemlibra® were injection site reactions, with no new safety signals observed. No thrombotic microangiopathy or thrombotic events occurred in this study.
- • On November 2, 2017, Chugai Pharmaceutical announced that preliminary data from HAVEN 4 study , a Phase lll study with hemophilia A patients with or without inhibitors which examines emicizumab prophylaxis administered subcutaneously once every four weeks, and real-world data from a non-interventional trial in children under 12 years of ages with hemophilia A with inhibitors will be presented at The American Society of Hematology (ASH) 2017 .
- • On December 21, 2016, a Phase 3 trial sponsored by Roche was published on the NIH website ClinicalTrials.gov for emicizumab and is currently recruiting participants.
Is
general: Yes
