Treatment for Hemophilia A Approved by FDA

Published Online: Thursday, August 30th, 2018
Officials with the FDA have approved Bayer’s antihemophilic factor [recombinant] PEGylated-aucl, BAY94-9027 (Jivi), for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older, according to the company.
BAY94-9027 is a recombinant factor VIII replacement therapy with a half-life of 17.9 hours. The initial recommended regimen is twice weekly (30-40 IU/kg), but dosing can be adjusted every 5 days (45-60 IU/kg) and can be further adjusted individually to less or more frequency based on bleeding episodes, according to Bayer.
The drug is also approved for on-demand treatment and the perioperative management of bleeding in the same population.
This approval is based on data from the 36-week phase 2/3 PROTECT VIII clinical trial, which included 126 previously treated patients 12 years or older with severe hemophilia A. Treatment with BAY94-9027 demonstrated bleed protection and safety of up to a median of 1.9 years. The drug was well tolerated in the majority of adult and adolescent patients. 
“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,” lead trial investigator Mark Reding, MD, associate professor of medicine at the University of Minnesota, said in a prepared statement.
The most commonly reported adverse effects in the trial were headache, cough, nausea, and fever. A FVIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a FVIII inhibitor.
BAY94-9027 is Bayer’s third FDA-approved hemophilia A treatment, according to the press release.

Bayer Receives FDA for Jivi, New Hemophilia A Treatment With Step-Wise Prophylaxis Dosing Regimen [news release]. Bayer’s website. Accessed August 30, 2018. 

Current Issue

The Educated Patient

Emily C. Hayes, PharmD Candidate
Colds, coughs, and a relentless influx of sick patients in retail health clinics keep the health care providers who work there very busy.
Kristen Marjama, DNP, APRN-BC
Although the rate of foot and leg amputation has greatly declined over the past 2 decades, increasing awareness for macrovascular and microvascular complications of diabetes is essential because diabetes is the leading cause of lower-limb amputations in the United States.
Kristen Marjama, DNP, FNP-BC
Gluten proteins found in barley, rye, and wheat trigger systemic injury primarily to the small intestine, but they can also affect the joints, liver, skin, uterus, and other organs.
Kristen Marjama, DNP, FNP-BC
It is that time of year again, when health care providers see an increase in patient volume because no one has time to be sick.
$vacMongoViewPlus$ $vAR$
Contemporary Clinic
MJH Associates
American Journal of Managed Care
MD Magazine
Pharmacy Times
Specialty Pharmacy Times
Targeted Oncology
About Us
Contact Us
Terms & Conditions
Pharmacy Healthcare & Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-257-0701

Copyright Contemporary Clinic 2018
Pharmacy Healthcare & Communications, LLC. All Rights Reserved.