BrightInsight has launched a web-based dosing calculator to help physicians select the correct loading and maintenance dose of the treatment Hemlibra according to the body measurements of their patients with hemophilia A.
The dosing calculator, launched with the support of Hemlibra’s manufacturer, Roche, will support the correct and long-term use of the treatment based on approved dosing recommendations.
“This is a great initiative for regulated digital health that provides a simple and convenient solution for physicians,” Kal Patel, MD, president and CEO of BrightInsight said in a press release.
Hemlibra is a man-made antibody that targets both factor IXa and factor X clotting factors at the same time. The treatment is designed to bring these molecules together and facilitate the activation of the natural coagulation pathways, subsequently restoring the blood clotting process in people with hemophilia A.
It is the only available prophylactic (preventive) therapy that can be administrated to both patients with and without factor VIII inhibitors through subcutaneous (under the skin) injection and multiple dosing regimens — once weekly, or every two or four weeks.
The approval of Hemlibra was based on positive data from two major clinical trials — the Phase 3 HAVEN 3 (NCT02847637) and HAVEN 4 (NCT03020160) studies — in which prophylactic treatment with Hemlibra was associated with a significant decrease in treated bleeds compared with no prophylactic treatment.
The HAVEN 3 study showed that preventive treatment, administrated once a week or every two weeks, could reduce bleeding episodes by 96%–97%, compared with no prophylactic treatment. Hemlibra was also able to reduce treated bleeds by 68% compared with previous prophylactic treatment, based on intra-patient comparisons.
The HAVEN 4 trial, which enrolled 48 adult and adolescent patients with hemophilia A regardless of factor VIII inhibitors status, evaluated Hemlibra’s potential to manage bleeds when dosed every four weeks. Results showed that after at least 24 weeks of treatment with Hemlibra, 56.1% of patients had zero bleeds, and 90.2% had three or fewer bleeds. These findings confirmed that the treatment could effectively control bleeding, even when administrated every four weeks.
Hemlibra is currently available in more than 60 countries worldwide to prevent or reduce the frequency of bleeds in hemophilia A patients with factor VIII inhibitors.