Bayer to present new data from its hemophilia A portfolio at the International Society of Thrombosis and Haemostasis (ISTH) 2019 annual congress
WHIPPANY, N.J., June 26, 2019 /PRNewswire/ -- Bayer will present new data highlighting clinical outcomes from its hemophilia A portfolio, which include long-term data from the PROTECT VIII investigational study evaluating use of Jivi(® )antihemophilic factor (recombinant) PEGylated-aucl. These data will be presented during the XXVII Congress of the International Society on Thrombosis and Haemostasis (ISTH), taking place July 6-10, 2019 in Melbourne, Australia.
"For over 30 years, we've had a steadfast focus on looking for new ways to understand how patients can benefit from our portfolio of hemophilia A therapies, and these data bring to light important insights we believe can inform treatment strategies for patients," said Aleksandra Vlajnic, MD, vice president, Bayer Medical Affairs. "We're committed to contributing to future advancements for the hemophilia A community."
Among the six abstracts of antihemophilic factor (recombinant) PEGylated-aucl, Bayer will present data on efficacy and safety, target joint resolution and patient-reported outcomes from patients exiting the long-term PROTECT VIII Extension Study.
All abstracts regarding Bayer's portfolio therapies featured at the ISTH 2019 Congress are listed below. Abstracts may discuss uses outside of the approved indication.
Jivi(®) antihemophilic factor (recombinant) PEGylated-aucl (BAY 94-9027)
-- PB0229: Accuracy of BAY 94-9027 potency measurements using FVIII assays
available in Japan
-- Date/Time: Sunday, July 7, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Sho Shinohara, MD
-- PB1434: Comparing qualitative and quantitative data on BAY 94-9027, a
new extended half-life recombinant factor VIII (EHL-rFVIII) for the
treatment of hemophilia A: a mixed-method research approach
-- Date/Time: Tuesday, July 9, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Emilo Musi, MD
-- PB1450: Target joint resolution in patients with hemophilia A receiving
long-term prophylaxis with BAY 94-9027
-- Date/Time: Tuesday, July 9, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Mark Reding, MD
-- PB1427: Effectiveness and safety of real-world treatment with BAY
94-9027 in previously treated patients with hemophilia A: Rationale and
design of the HEM-POWR study
-- Date/Time: Tuesday, July 9, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Martin Sanabria, MD
-- PB1426: HLA-DR processing and presentation of two peptide antigen
clusters in PEG-BDD-FVIII (BAY94-9027) by dendritic cells is impaired
resulting in defective t-helper response in vitro
-- Date/Time: Tuesday, July 9, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Pedro Paz, MD
-- OC 70.2: Efficacy and safety of BAY 94-9027 is sustained for 5 years:
outcomes in 36 patients in the PROTECT VIII extension study
-- Date/Time: Wednesday, July 10, 10:15am-11:30am
-- Session: Plenary Session, Oral Presentation
-- Location: Plenary Hall
-- Presenter: Mark Reding, MD
Kovaltry(®) Antihemophilic Factor (Recombinant) (BAY 81-8973)
-- PB1454: Pharmacokinetic properties of BAY 81-8973: real-world data from
the TAURUS non-interventional study
-- Date/Time: Tuesday, July 9, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Phu Quoc LE, MD
Other
-- PB0210: Physical activity and treatment adherence in persons with
hemophilia receiving standard half-life (SHL) vs. extended half-life
(EHL) replacement Factor VIII (FVIII): findings from the HemACTIVE
Patient Survey
-- Date/Time: Sunday, July 7, 6:30pm-7:30pm
-- Session: Poster Presentation
-- Location: Exhibition Hall
-- Presenter: Mark Skinner, MD
About Hemophilia A
Hemophilia affects approximately 400,000 people around the world, including an estimated 20,000 in the U.S. today. It is a largely inherited disorder in which one of the proteins needed to form blood clots is missing or reduced. In hemophilia A, the most common type of hemophilia, blood clotting is impaired as a result of a lack or defect of coagulation factor VIII. Patients therefore repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage. External injuries, even if they seem trivial, can have serious consequences if not treated appropriately.
Hemophilia treatment has advanced considerably over the past decades, with life expectancy for people with hemophilia significantly increasing from about 11.4 years in 1920 to a potentially normal life span today.
Jivi(®) antihemophilic factor (recombinant) PEGylated-aucl
Indications and Important Safety Information
INDICATIONS
-- Jivi is an injectable medicine used to replace clotting factor (Factor
VIII or antihemophilic factor) that is missing in people with hemophilia
A.
-- Jivi is used to treat and control bleeding in previously treated adults
and adolescents (12 years of age and older) with hemophilia A. Your
healthcare provider may also give you Jivi when you have surgery. Jivi
can reduce the number of bleeding episodes in adults and adolescents
with hemophilia A when used regularly (prophylaxis).
-- Jivi is not for use in children below 12 years of age or in previously
untreated patients.
-- Jivi is not used to treat von Willebrand disease.
IMPORTANT SAFETY INFORMATION
-- You should not use Jivi if you are allergic to rodents (like mice and
hamsters) or to any ingredients in Jivi.
-- Tell your healthcare provider about all of your medical conditions that
you have or had.
-- Tell your healthcare provider if you have been told that you have
inhibitors to Factor VIII.
-- Allergic reactions may occur with Jivi. Call your healthcare provider
right away and stop treatment if you get tightness of the chest or
throat, dizziness, decrease in blood pressure, or nausea.
-- Allergic reactions to polyethylene glycol (PEG), a component of Jivi,
are possible.
-- Your body can also make antibodies, called "inhibitors," against Jivi,
which may stop Jivi from working properly. Consult your healthcare
provider to make sure you are carefully monitored with blood tests for
the development of inhibitors to Factor VIII.
-- If your bleeding is not being controlled with your usual dose of Jivi,
consult your doctor immediately. You may have developed Factor VIII
inhibitors or antibodies to PEG and your doctor may carry out tests to
confirm this.
-- The common side effects of Jivi are headache, cough, nausea, and fever.
-- These are not all the possible side effects with Jivi. Tell your
healthcare provider about any side effect that bothers you or that does
not go away.
For additional important risk and use information, please see full Prescribing Information.
KOVALTRY(®) Antihemophilic Factor (Recombinant)
Indications and Important Safety Information
INDICATIONS
-- KOVALTRY(®) is a medicine used to replace clotting factor (Factor VIII
or antihemophilic factor) that is missing in people with hemophilia A.
-- KOVALTRY(®) is used to treat and control bleeding in adults and
children with hemophilia A.
-- KOVALTRY(®) can reduce the number of bleeding episodes in adults and
children with hemophilia A when used regularly (prophylaxis). Your
healthcare provider may give you KOVALTRY(®) when you have surgery.
-- KOVALTRY(®) is not used to treat von Willebrand Disease.
IMPORTANT SAFETY INFORMATION
-- You should not use KOVALTRY(®) if you are allergic to rodents (like
mice and hamsters) or any ingredients in KOVALTRY(®).
-- Tell your healthcare provider if you have heart disease or are at risk
for heart disease.
-- The common side effects of KOVALTRY(®) are headache, fever, and itchy
rash.
-- Allergic reactions may occur with KOVALTRY(®). Call your healthcare
provider right away and stop treatment if you get tightness of the chest
or throat, dizziness, decrease in blood pressure, and nausea.
-- Your body can also make antibodies, called "inhibitors," against
KOVALTRY(®), which may stop KOVALTRY(®) from working properly. Consult
with your healthcare provider to make sure you are carefully monitored
with blood tests for the development of inhibitors to Factor VIII.
-- Tell your healthcare provider about any side effect that bothers you or
that does not go away.
-- Call your healthcare provider right away if bleeding is not controlled
after using KOVALTRY(®).
For additional important risk and use information, please see full Prescribing Information.
You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.us.
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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