Bayer Announces the Approval of Jivi for Hemophilia A in Europe

Bayer Announces the Approval of Jivi for Hemophilia A in Europe

Jivi (BAY94-9027), a lab-made version of the blood clotting factor VIII (FVIII), has been approved by the European Commission for the prophylactic (preventative) treatment of hemophilia A in patients older than 12, Bayer announced.

The recommended prophylaxis for Jivi administration is every five days, every seven days or twice a week, depending on the patient.

Hemophilia is a genetic disorder that affects the body’s blood-clotting ability, which can lead to excessive bleeding. In hemophilia A, this inability of the blood to clot is caused by the lack of FVIII. Current treatments for hemophilia A are based on providing the missing FVIII to patients prophylactically to avoid spontaneous bleeding episodes.

However, these replacement therapies have a downside: the reduced stability and activity of the artificial FVIII in the blood often means frequent infusions, which can affect a patient’s quality of life.

Jivi was designed to overcome this limitation through the addition of PEG, or PEGylation, a substance that, once bound to FVIII, improves its stability and significantly prolongs its half-life in the blood compared with other currently available therapies.

“Infusion frequency is a major challenge for people with hemophilia A and we believe with Jivi we can address those needs without compromising good bleed protection,” Elena Santagostino, director of the hemophilia unit for adult and pediatric patients with inherited bleeding disorders at the Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre of the Cà Granda Foundation, Maggiore Hospital Policlinico of Milan, Italy, said in a news release.

“With the opportunity to offer a treatment with sustained levels of FVIII for a longer period in the blood and thus provide good bleed protection, patients and family members can feel confident that they or their loved one is well-protected from bleeds and can spend more time enjoying a wider range of activities together,” Santagostino said.

After being approved in the U.S. by the Food and Drug Administration (FDA), in Canada and recently in Japan, Jivi finally has been approved in Europe, based on data from the Phase 2/3 PROTECT VIII (NCT01580293) trial.

According to data from the trial, 74% of the patients receiving Jivi once a week, and all patients receiving Jivi every five days were protected from spontaneous bleeding episodes. Over the course of the trial and its subsequent extension studies, which lasted more than five years, prophylactic treatment with Jivi was shown to be highly effective and safe.

After Kogenate (BAY14-2222) and Kovaltry (BAY 81-8973), Jivi is the third FVIII replacement therapy for the treatment of hemophilia A developed and marketed by Bayer.

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