FDA approves Bayer’s Jivi
Bayer’s Jivi, a prophylactic treatment for hemophilia A, has been approved by the Food and Drug Administration, the company announced Thursday. The drug has an initial recommended regimen of twice weekly, with the ability to dose every five days, and to adjust to less or more frequent dosing based on a patient’s bleeding episode.
"Today's approval builds on our 25-year partnership with the hemophilia community and underscores our commitment to developing new therapies that help meet the needs of patients living with this life-long disease," said Carsten Brunn, president of Bayer Pharmaceuticals, Americas region. "Jivi's proven efficacy with its unique dosing regimen is an important benefit to patients that we look forward to bringing to the global community, as we pursue additional regulatory approvals for Jivi in other regions around the world."
The drug works by replacing factor VII — which is missing in adults and adolescents 12 years old and older with hemophilia A, Bayer said. Jivi also has been approved for on-demand treatment and perioperative bleeding management in the same population.
"As a physician who treats hemophilia A patients with a range of individualized needs, Jivi's approved dosing allows me to adjust frequency based on their bleed episodes to maintain protection from bleeds, which is a serious concern among patients," said Mark Reding, lead investigator of the clinical trial the approval was based on and associate professor of medicine at the University of Minnesota. "Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles."
"Today's approval builds on our 25-year partnership with the hemophilia community and underscores our commitment to developing new therapies that help meet the needs of patients living with this life-long disease," said Carsten Brunn, president of Bayer Pharmaceuticals, Americas region. "Jivi's proven efficacy with its unique dosing regimen is an important benefit to patients that we look forward to bringing to the global community, as we pursue additional regulatory approvals for Jivi in other regions around the world."
The drug works by replacing factor VII — which is missing in adults and adolescents 12 years old and older with hemophilia A, Bayer said. Jivi also has been approved for on-demand treatment and perioperative bleeding management in the same population.
"As a physician who treats hemophilia A patients with a range of individualized needs, Jivi's approved dosing allows me to adjust frequency based on their bleed episodes to maintain protection from bleeds, which is a serious concern among patients," said Mark Reding, lead investigator of the clinical trial the approval was based on and associate professor of medicine at the University of Minnesota. "Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles."