- ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] is built on ADVATE [Antihemophilic Factor (Recombinant)], a well-established treatment for hemophilia A patients with more than 12 years of patient experience
- Proprietary pegylation technology1 to extend the time between treatments and offer simple, twice-weekly dosing schedule compared to conventional 3-4 doses weekly
- ADYNOVATE prophylaxis resulted in 95 percent fewer bleeds compared to on-demand treatment in the pivotal study; nearly 40 percent of treated patients receiving ADYNOVATE prophylaxis experienced zero bleeds2
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"People with hemophilia want to minimize their bleeds and not let their hemophilia dictate their lives; having options empowers patients to make the best decisions for their personal care," said
"ADYNOVATE represents Baxalta's commitment to meeting the needs of hemophilia A patients who want bleed reduction with a dosing schedule that better fits their personal needs," said
In the pivotal phase 3 clinical trial, which served as the foundation for the approval, ADYNOVATE demonstrated efficacy in treating hemophilia patients through routine prophylaxis as well as for on-demand bleeding episodes. Patients, 12 to 65 years of age, in the prospective, global, multi-center, open label, non-randomized study were assigned to either twice weekly prophylaxis (40-50 IU/kg, n=120) or on-demand treatment (10-60 IU/kg, n=17) with ADYNOVATE. The study found that previously-treated patients in a twice-weekly prophylaxis arm had 95 percent fewer annual bleeds compared to those treated on-demand [median annual bleed rate (ABR) 1.9 vs. 41.5, respectively]. During the study, 38 percent (n=120) of prophylaxis-treated patients experienced zero bleeds. Moreover, 57 percent of patients experienced zero joint bleeds based on six months of prophylaxis with ADYNOVATE.2
Nearly all (98 percent) of patients on prophylaxis with ADYNOVATE did not have a dose adjustment in the study. Nearly all (96 percent) bleeding episodes (n=591) were controlled with one or two infusions of ADYNOVATE. No patients developed inhibitors to the treatment; the most common adverse reactions (=1 percent of subjects) were headache and nausea.2
ADYNOVATE will be available in
Hemophilia A is a challenging chronic disease; treatment regimens require regular infusions to reduce the risk of bleeding. Working closely with their health professionals, many patients continue to seek treatment options that can be better personalized to fit their needs, providing both effective bleed protection and simplified dosing schedules. Today, the disease affects approximately 16,000 people in
Through a collaboration with
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes
• Routine prophylaxis to reduce the frequency of bleeding episodes
ADYNOVATE is not indicated for the treatment of von Willebrand disease.
DETAILED IMPORTANT RISK INFORMATION
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).
WARNINGS & PRECAUTIONS
Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
Common adverse reactions (=1% of subjects) reported in the clinical studies were headache and nausea.
For Full Prescribing Information, visit
ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:
- Control and prevention of bleeding episodes
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy and safety profile for the treatment of hemophilia A. 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 virtually eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is the world's most prescribed FVIII treatment. It is currently approved in 64 countries worldwide, including
Detailed Important Risk Information for ADVATE [Antihemophilic Factor (Recombinant)]
ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.
WARNINGS & PRECAUTIONS
Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting.
Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (frequency =5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.
Please see full prescribing information for ADVATE at: www.advate.com/assets/pdf/advate_iri_pi.pdf.
This release includes forward-looking statements concerning ADYNOVATE, including expectations with regard to clinical trials, future regulatory actions, expected launch plans and potential impact on patients. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond
All other product brands or trademarks appearing herein are the property of their respective owners.
1. Proprietary pegylation technology exclusively licensed from
2. Konkle, Barbara, et al. Pegylated, full-length, recombinant factor VIII for prophylactic and on- demand treatment of severe hemophilia A. Blood.