| | WHIPPANY, N.J. /PRNewswire/ --Bayer announced today that seven abstracts from its Hemophilia portfolio and development pipeline have been accepted for presentation during Scientific Sessions at the 2018 American Society of Hematology (ASH) Annual Meeting, December 1 – December 4, in San Diego, CA. The presentations include five posters highlighting new data for Jivi®, antihemophilic factor (recombinant) PEGylated-aucl (Bay 94-9027), one on new data for Kovaltry®, Antihemophilic Factor (recombinant), and one poster on Anti-TFPI research from Bayer’s hematology pipeline. “Bayer’s 25-year history of research and development in hemophilia A is exemplified by the wealth of data from our clinical program that’s being presented at this year’s congress,” said Aleksandra Vlajnic, MD, Vice President of Medical Affairs at Bayer. “These efforts underscore our commitment to science and help to inform physicians when having clinical discussions together with their patients.” The presentations being made are listed below. Please note the posters presentations may discuss a use outside of the approved indications. - Abstract 1189: Extended Interval Prophylaxis With BAY 94-9027 For > 4 Years Leads To Median Spontaneous Annualized Bleeding Rate < 1 in the PROTECT VIII Extension
- Date/Time: Saturday, December 1, 6:15pm-8:15pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I
- Location: Hall GH, Convention Center
- Presenter: Mindy Simpson, MD, RUSH University Medical Center
- Abstract 1206: Decrease in Overall and Joint Bleeding Rates With Extended-Interval Dosing
- Date/Time: Saturday, December 1, 6:15pm-8:15pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I
- Location: Hall GH, Convention Center
- Presenter: Mark Reding, MD, University of Minnesota
- Abstract 1176: Pharmacodynamics, Pharmacokinetics and Safety of BAY 1093884, an Antibody Directed Against Human TFPI, in Patients With Factor VIII or IX Deficiency (With and Without Inhibitors): a Phase 1 Study
- Date/Time: Saturday, December 1, 6:15pm-8:15pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
- Location: Hall GH, Convention Center
- Presenter: Pratima Chowdary, MD, Royal Free London NHS Foundation Trust
- Abstract 1209: Improved Pharmacokinetic Profile for BAY 81-8973 Due to Increased Branching and Sialylation of N-Linked Glycans of Recombinant Factor VIII
- Date/Time: Saturday, December 1, 6:15pm-8:15pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
- Location: Hall GH, Convention Center
- Presenter: John Teare, Ph.D. Director, Late Stage Program Management, Biological Development, Bayer Pharmaceuticals
- Abstract 2486: Characteristics of Bleed-free Patients on Every-5-day Dosing in the PROTECT VIII (BAY 94-9027) Study
- Date/Time: Sunday, December 2, 6:00pm-8:00pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
- Location: Hall GH, Convention Center
- Presenter: Elena Santagostino, MD, Centro Emofilia e Trombosi A. Bianchi Bonomi
IRCCS Fondazione Ca’ Granda, Ospedale Maggiore Policlinico - Abstract 2492: Efficacy and Safety of BAY 94-9027 is Sustained for 5 Years: Outcomes in 33 Patients in the PROTECT VIII Extension Study
- Date/Time: Sunday, December 2, 6:00pm-8:00pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
- Location: Hall GH, Convention Center
- Presenter: Mark Reding, MD, University of Minnesota
- Abstract 2481: BAY 94-9027 Can Be Accurately Measured Across Regions With Appropriate One-Stage Assay Reagent Use
- Date/Time: Sunday, December 2, 6:00pm-8:00pm
- Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
- Location: Hall GH, Convention Center
- Presenter: Rajiv Pruthi, MD, Mayo Clinic
Jivi 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 the full Prescribing 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.
*Compared to other recombinant Factor VIII products. Reference: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. 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. Bayer: Science for a Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.us. Our online press service is just a click away:
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