The following is a press release from HEMA Biologics.
HEMA BiologicsTM Announces FDA Approval of SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors
Louisville, KY – April 6, 2020
HEMA Biologics, LLC, (“HEMA Biologics”) today announced that the U.S. Food and Drug Administration (FDA) approved SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] as the first new bypassing agent in over 20 years for adults and adolescents (12 years of age and older) with hemophilia A and B with inhibitors.
“Through a joint venture with LFB SA, we are excited to be able to bring to the U.S. a meaningful treatment option for hemophilia patients with inhibitors,” said P. Breckinridge (“Breck”) Jones, CEO, HEMA Biologics. “SEVENFACT is an innovative analog of human Factor VIIa and the result of a decades-long development effort across three continents. This approval is representative of HEMA Biologics’ and LFB’s deep commitment to improving patient outcomes. SEVENFACT is manufactured using LFB’s proprietary and state of the art rPROTM technology, creating a safe and reliable method of protein production.”
Several options have been made available for bleeding disorders in recent years, yet there were no new treatments for inhibitor-related bleeding. “Patients and families impacted by inhibitors have limited options available for the treatment and control of bleeding. As inhibitor patients continue to suffer the consequences of bleeding, bypassing agents will remain an essential part of disease management,” explains Dr. Allan Alexander, Vice President of Medical Affairs at HEMA Biologics. “We are pleased to bring SEVENFACT, a treatment that provides a proven hemostatic benefit in the setting of inhibitor-related bleeding along with demonstrated bleed resolution using a single dose.”
The approval of SEVENFACT was based on data from the pivotal phase 3 trial, PERSEPT 1. This clinical trial evaluated 468 mild, moderate, and severe bleeding episodes in 27 adolescent and adult hemophilia A and B patients with inhibitors in a randomized, multicenter, open-label, two initial dose regimens, cross-over trial design. Both initial dose regimens met the primary endpoint of bleed control by 12 hours: 91% of mild or moderate bleeding episodes treated with an initial 225 mcg/kg dose achieved hemostatic efficacy at 12 hours; the median time to hemostatic response was 3 hours, corresponding to 1 dose of SEVENFACT. The median time to hemostatic response for bleeding episodes treated with an initial 75 mcg/kg dose was 6 hours (median of 2 doses SEVENFACT), with 82% of bleeding episodes achieving hemostatic efficacy at 12 hours. By 24 hours, hemostatic efficacy was retained in 97.6% of bleeding episodes treated with the 75 mcg/kg dose regimen, and 99.5% of bleeding episodes treated with the 225 mcg/kg dose regimen, without requiring any alternative therapy.
HEMA Biologics has commercialization and distribution rights for SEVENFACT in the U.S. and Canada.
To read the entire statement from HEMA Biologics, you can visit their website here.
“Through a joint venture with LFB SA, we are excited to be able to bring to the U.S. a meaningful treatment option for hemophilia patients with inhibitors,” said P. Breckinridge (“Breck”) Jones, CEO, HEMA Biologics. “SEVENFACT is an innovative analog of human Factor VIIa and the result of a decades-long development effort across three continents. This approval is representative of HEMA Biologics’ and LFB’s deep commitment to improving patient outcomes. SEVENFACT is manufactured using LFB’s proprietary and state of the art rPROTM technology, creating a safe and reliable method of protein production.”
Several options have been made available for bleeding disorders in recent years, yet there were no new treatments for inhibitor-related bleeding. “Patients and families impacted by inhibitors have limited options available for the treatment and control of bleeding. As inhibitor patients continue to suffer the consequences of bleeding, bypassing agents will remain an essential part of disease management,” explains Dr. Allan Alexander, Vice President of Medical Affairs at HEMA Biologics. “We are pleased to bring SEVENFACT, a treatment that provides a proven hemostatic benefit in the setting of inhibitor-related bleeding along with demonstrated bleed resolution using a single dose.”
The approval of SEVENFACT was based on data from the pivotal phase 3 trial, PERSEPT 1. This clinical trial evaluated 468 mild, moderate, and severe bleeding episodes in 27 adolescent and adult hemophilia A and B patients with inhibitors in a randomized, multicenter, open-label, two initial dose regimens, cross-over trial design. Both initial dose regimens met the primary endpoint of bleed control by 12 hours: 91% of mild or moderate bleeding episodes treated with an initial 225 mcg/kg dose achieved hemostatic efficacy at 12 hours; the median time to hemostatic response was 3 hours, corresponding to 1 dose of SEVENFACT. The median time to hemostatic response for bleeding episodes treated with an initial 75 mcg/kg dose was 6 hours (median of 2 doses SEVENFACT), with 82% of bleeding episodes achieving hemostatic efficacy at 12 hours. By 24 hours, hemostatic efficacy was retained in 97.6% of bleeding episodes treated with the 75 mcg/kg dose regimen, and 99.5% of bleeding episodes treated with the 225 mcg/kg dose regimen, without requiring any alternative therapy.
HEMA Biologics has commercialization and distribution rights for SEVENFACT in the U.S. and Canada.
To read the entire statement from HEMA Biologics, you can visit their website here.
