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Roche's Hemlibra shows clinically meaningful bleed control in four-week doses


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Roche's Hemlibra shows clinically meaningful bleed control in four-week doses

Roche Holding AG said its hemophilia drug Hemlibra, previously known as ACE910, showed clinically meaningful bleed control when given as a preventive treatment once every four weeks.

Interim results from Roche unit Genentech's phase 3 Haven 4 study are consistent with previous results for Hemlibra where patients were dosed once a week or every two weeks.

No new safety signals were observed.

"We are encouraged that Hemlibra prophylaxis administered by injection under the skin once every four weeks showed clinically meaningful bleed control in people with hemophilia A. Together with the findings from other phase 3 studies, these interim results support the potential for Hemlibra to be dosed at different schedules, allowing patients to choose the option that's right for them," Sandra Horning, Genentech's chief medical officer and head of global product development, said in a news release.

The study enrolled 48 patients aged 12 years or older, with previously treated hemophilia A.

Genentech said it plans to submit the study data for approval to health authorities around the world.

Hemophilia A is an inherited disorder in which a person's blood is unable to clot properly, leading to uncontrolled and often spontaneous bleeding. Hemophilia affects about 20,000 people in the U.S.