Berlin, Germany – July 9 2017 - Shire International GmbH has obtained a preliminary injunction in a court of Hamburg, Germany against F. Hoffmann-La Roche Ltd. (Roche) to address incomplete and misleading statements that may impact important issues of patient safety regarding the investigational treatment emicizumab.
Under the injunction, Shire seeks to prevent further dissemination of the inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 trial of emicizumab, specifically the assertion that “all events occurred when repeated high aPCC (activated Prothrombin Complex Concentrate) doses were used concurrently with emicizumab.” The injunction also seeks to correct promotion of the primary data results relative to “treated bleeds” (a secondary endpoint) as compared to the primary endpoint of “number of bleeds over time” established at the outset of the trial.
Based on Roche’s publically available information to date (as of 7 July 2017), physicians, patients and caregivers may be misinformed about the appropriate management of breakthrough bleeds uncontrolled by emicizumab. In addition, through these actions, Shire believes Roche has unlawfully disparaged Shire’s proven bypassing agent, FEIBA (Anti-Inhibitor Coagulant Complex). Shire has issued multiple unheeded requests to Roche in an effort to resolve these concerns in an appropriate manner. As a result, Shire made the decision to seek court intervention.
Shire’s goal with this action is to ensure the hemophilia community receives sufficient, accurate information from Roche about the reported serious adverse events (SAEs) in the Phase 3 emicizumab trial, enabling physicians and their patients to make properly informed decisions about patient care.
As the global leader in rare hematology, Shire advocates in the interest of patient safety and continually defends the demonstrated 40-year safety profile of FEIBA.
The preliminary injunction is an interim measure which can be appealed by Roche.
International Safety Information FEIBA (Factor VIII Inhibitor Bypassing Activity)
Please consult the Feiba Summary Product Characteristics (SPC) before prescribing, particularly in relation to dosing and treatment monitoring.
Hypersensitivity to the product or any of the components, disseminated intravascular coagulation (DIC) and acute thrombosis or embolism (including myocardial infarction).
Special warnings and precautions for use
Thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, have occurred in the course of treatment with FEIBA. At the first signs or symptoms of thromboembolic events, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated.
FEIBA can precipitate allergic-type hypersensitivity reactions; these reactions can be severe and can be systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported.
If clinically significant changes in blood pressure or pulse rate, respiratory distress, coughing or chest pain occur, the infusion is to be discontinued immediately and appropriate diagnostic and therapeutic measures are to be initiated.
In vitro tests, such as aPTT, whole blood clotting time (WBCT) may not correlate with the clinical picture.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived products including FEIBA.
(≥1/100 to <1/10)
|Hypersensitivity, Headache, Hypotension, Rash, Hepatitis B surface antibody positive.|
|Not known||Disseminated intravascular coagulation (DIC), Increase of inhibitor titer (anamnestic response),Urticaria, Anaphylactic reaction, Paresthesia, Hypoaesthesia, Thrombotic stroke, Embolic stroke, Somnolence, Dizziness, Dysgeusia, Cardiac infarction, Tachycardia, Thrombosis, Venous thrombosis, Arterial thrombosis, Embolism, Hypotension, Hypertension, Flushing, Pulmonary embolism, Bronchospasm, Wheezing, Cough, Dyspnea, Vomiting, Diarrhea, Abdominal discomfort, Nausea, Sensation of numbness in the face, Angioedema, Urticaria, Pruritus, Pain at the injection site, Malaise, Feeling hot, Chills, Pyrexia, Chest pain, Chest discomfort, Blood pressure decreased.|
NOTES TO EDITORS
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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