BRUSSELS, February 27, 2014 - Baxter International Inc. (NYSE:BAX) today presented clinical data on Baxter's leading recombinant factor VIII treatment, including interim data from the first year of observation from the AHEAD (ADVATE HaEmophilia A Database) study, a four-year outcomes registry of hemophilia A patients treated with ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method]. These data were presented during the European Association for Haemophilia and Allied Disorders (EAHAD) meeting in Brussels, Belgium.
These real-world data, which support the clinical experience of prophylaxis treatment with ADVATE, found that the majority of patients (55.3%) on prophylaxis had fewer than two bleeding episodes per year, with a median annual bleed rate (ABR) of 1.1. Of these patients, 51 percent experienced no bleeds during one year of treatment.
"ADVATE delivers proven clinical performance, with similar data in routine clinical settings as those reported in controlled clinical trials. The growing body of prophylaxis data provides physicians and patients even more support for this prophylactic treatment and add to the robust body of evidence available on its safety and efficacy," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "These data strongly support the concept of treating prophylactically to reduce the risk of bleeding episodes, a measurable target that we continue to pursue as part of our vision of a bleed free world."
About the AHEAD Study
A total of 562 hemophilia A patients have been enrolled to date, 77 percent of whose hemophilia is severe. Of the 115 patients from the European arm who have been followed for at least one year and have provided data on their annual bleed rate, 85 were treated with ADVATE prophylactically and 30 were treated on-demand. Of the patients on prophylactic treatment, more than half (55.3%) reached an ABR of 0-2; and 51 percent of this group experienced no bleeds during one year of treatment. The median ABR was 1.1 for prophylaxis and 11.8 for on-demand patients, consistent with previously published studies. The overall effectiveness was rated as "excellent or good" in
97.6 percent for prophylaxis treatment and 92.9 percent for on-demand treatment.
Fifty-eight patients reported adverse events (AEs) of which three were deemed treatment related (two cases of low titer inhibitors and one of hypersensitivity). None of the reported AEs led to study drug withdrawal or interruption. The study continues to enroll patients to obtain significant long-term outcomes data on ADVATE.
The ongoing AHEAD study intends to capture long-term data on 850 patients with hemophilia A receiving ADVATE treatment under routine clinical practice in Europe, Canada and South America, including both on-demand and prophylaxis regimens. Study endpoints include joint health outcomes, annualized bleeding rates (ABR), health-related quality of life (HRQol), and safety. The study will enroll 850 patients (500 in Germany, 350 across Europe, Canada and South America), and will follow participants for four years.
Other Baxter Data at EAHAD
Baxter is presenting on research outcomes during the EAHAD meeting, such as:
- Data from a meta-analysis of ADVATE post-authorization safety studies, showcasing ADVATE's safety and efficacy profile among patients with low titer inhibitors or a personal history of inhibitors (abstract number 1085);
- A model comparing time spent below and/or above specific factor VIII levels under various prophylaxis dosing scenarios with native vs. extended half-life factor VIII products, considering the importance for active patients to remain within recommended factor VIII levels (abstract number 1153); and
- Enrollment status and update on the PROLONG-ATE study evaluating the efficacy and safety of extended half-life investigational treatment BAX-855 for prophylactic and episodic treatment of severe hemophilia A (abstract number 1134).
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. The product is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy and safety profile. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is approved in 61 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay and Venezuela.
Detailed Important Risk Information for ADVATE
ADVATE is contraindicated in patients with known anaphylaxis to mouse or hamster protein or other constituents of the product.
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesias, rash, flushing, face swelling, urticaria, dyspnea, and pruritus. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs).
If expected plasma FVIII levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures FVIII inhibitor concentration.
The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII.
The most common adverse reactions observed in clinical trials (frequency greater than or equal to 10 percent of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.
Please see full prescribing information for ADVATE at: http://www.baxter.com/downloads/healthcare_professionals/
About Baxter in Hemophilia
Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning Baxter's AHEAD study. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: actions of regulatory bodies and other governmental authorities; additional clinical results; changes in laws and regulations; product quality or supply or patient safety issues; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.