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Biopharmaceuticals FDA

 News Release - April 6, 2020

HEMA Biologics(TM) Announces FDA Approval of SEVENFACT(R) [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors

First new bypassing agent approved for the treatment and control of bleeding episodes in hemophilia A and B patients with inhibitors in over 2 decades

Median number of infusions required to achieve bleeding control in the first 12 hours was 1 (225 mcg/kg) or 2 (75 mcg/kg)


LOUISVILLE, Ky., April 6, 2020 -- (Healthcare Sales & Marketing Network) -- 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 rPRO™ 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.

About PERSEPT 1

PERSEPT 1 (Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trial) was designed to evaluate the safety and efficacy of SEVENFACT in 27 adults and adolescents (12 years of age or older) with hemophilia A or B with inhibitors to factor VIII or factor IX, respectively. Subjects were randomized to one of two initial dose regimens at enrollment and crossed over to the alternate initial dose regimen every 3 months for the duration of the trial. Mild or moderate bleeding episodes were treated with either 75 mcg/kg every 3 hours; or with an initial dose of 225 mcg/kg followed (after 9 hours) by 75 mcg/kg injections if needed. Severe bleeding episodes were treated with an initial dose of 225 mcg/kg followed (after 6 hours) by 75 mcg/kg every 2 hours as needed.

Indications and Usage

SEVENFACT [coagulation factor VIIa (recombinant)-jncw] is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

Limitation of Use: SEVENFACT is not indicated for treatment of congenital factor VII deficiency.

Important Safety Information

WARNING: THROMBOSIS
  • Serious arterial and venous thrombotic events may occur following administration of SEVENFACT.
  • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive SEVENFACT.
  • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.
Warnings and Precautions
  • Patients with hemophilia A or B with inhibitors who have other risk factors for thrombosis may be at increased risk of serious arterial and venous thrombotic events.
  • Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT. Should symptoms occur, patients should discontinue SEVENFACT and seek appropriate medical intervention.
Adverse Reactions

The most common adverse reactions (incidence ≥1%) reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever.

Drug Interactions

Clinical experience with pharmacologic use of FVIIa-containing products indicates an elevated risk of serious thrombotic events when used simultaneously with activated prothrombin complex concentrates.

About Hemophilia A and B with Inhibitors

Inhibitors are antibodies formed in response to treatment of hemophilia A or B with factor VIII or factor IX replacement, respectively. The patient's immune system recognizes the factor replacement as a foreign protein and develops antibodies; this can make factor VIII or factor IX replacement ineffective for the control of bleeding.1,2

Approximately 30% of people with severe hemophilia A will develop an inhibitor to infused factor VIII during their lives, while up to 5% of people with severe hemophilia B will develop an inhibitor to infused factor IX.2

Since 1999, there have only been two approved bypassing agents indicated for use by hemophilia A or B patients impacted by inhibitors.

About HEMA Biologics

HEMA Biologics is a biopharmaceutical company, located in Louisville, KY. HEMA Biologics has commercialization and distribution rights for SEVENFACT in the U.S. and Canada. HEMA Biologics takes pride in the heritage of LFB, the developer and manufacturer of SEVENFACT.

The company is dedicated to meeting the needs of patients living with rare bleeding disorders, supporting the community that cares for them, and bringing meaningful products and services to the marketplace to help improve their daily lives.

About LFB

LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals, with blood-derived therapeutics in three major areas: immunology, haemostasis, and intensive care. LFB was founded in 1994 in France with the vision to provide treatment options to patients and currently markets 15 products in more than 30 countries.

References
  1. Ducore J, Lawrence JB, Simpson M, et al. Safety and dose-dependency of eptacog beta (activated) in a dose escalation study of non-bleeding congenital haemophilia A or B patients, with or without inhibitors. Haemophilia. 2017;23(6):844-851.
  2. Meeks SL, Leissinger CA. The evolution of factor VIIa in the treatment of bleeding in haemophilia with inhibitors. Haemophilia. 2019;25(6):911-918.


Source: HEMA Biologics

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