Health Canada approved Jivi as a treatment to prevent or reduce the frequency of bleeding episodes in patients age 12 or older who have received previous lines of treatment. The regulatory agency also approved the use of this novel therapy for the control and prevention of episodic bleeding, and peri-operative management of bleeding (surgical prophylaxis).
Jivi initially should be administrated twice weekly in a prophylactic regimen, followed by dosing every five days, which can be adjusted to less or more frequent dosing based on the individual patient’s frequency of bleeding episodes.
“We welcome the approval of Jivi by Health Canada,” Paul Wilton, president of the Canadian Hemophilia Society, said in a press release. “This will add another option for patients with hemophilia A in selecting the factor VIII replacement therapy that is right for them.”
Jivi, formerly known as BAY94-9027, is a man-made version of the clotting factor VIII (rFVIII) that was designed specifically to be more stable and have prolonged action than currently available replacement therapies for those living with with hemophilia A.
“Research shows Jivi’s novel structural design produces very predictable pharmacokinetics (the way the drug moves through the body). This makes it simpler to build effective treatment regimens and minimize the infusion frequency,” said Alfonso Iorio, MD, PhD, professor and researcher at McMaster University.
Health Canada’s decision was supported by results of the pivotal ongoing Phase 2/3 PROTECT VIII trial (NCT01580293).
Being conducted at several clinical sites worldwide, the study enrolled 141 adults and adolescents age 12 to 65 who had severe hemophilia A, and who had been previously treated with factor VIII. During the trial, researchers tested several dosing regimens of Jivi for on-demand treatment of bleeds and for prophylactic therapy, and evaluated the drug’s safety and effectiveness.
The patients included in the prophylactic therapy arm received the treatment for 36 weeks. Those who showed a good response to the treatment, without experiencing any safety issues, could continue the treatment for at least 100 accumulated exposure days.
Data first reported in 2014 showed that Jivi could achieve bleed protection with extended dosing intervals. In addition, it showed to effectively resolve 91% of acute and breakthrough bleed events with one or two infusions.
More recent data collected from 126 patients who completed the main study demonstrated that Jivi could effectively prevent bleeding episodes with a good safety profile of up to a median of 1.9 years, and up to 2.6 years.
Researchers also evaluated the effectiveness of Jivi in a major surgical setting in a different group of participants. In general, treatment with Jivi was well-tolerated, with the most frequent reported adverse side effects being headache, cough, and fever.
In August 2018, based on these positive results, the U.S. Food and Drug Administration approved the use of Jivi as a preventive therapy for hemophilia A in patients 12 and older.