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ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] approved
for treatment of patients 12 years and older with hemophilia A in
Japan - Built on ADVATE [Antihemophilic Factor (Recombinant)], the world's most widely used FVIII treatment, ADYNOVATE offers a simple, twice-weekly dosing schedule
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Approval expands access of ADYNOVATE to the nearly 5,000 people in
Japan with hemophilia A1
ADYNOVATE is built on ADVATE [Antihemophilic Factor (Recombinant)], the world's most widely used FVIII treatment for hemophilia A with more than 12 years of patient experience. ADYNOVATE leverages proprietary pegylation technology2 designed to extend the time FVIII is available in the body. The technology reduces the speed at which ADYNOVATE is cleared from the blood, resulting in increased circulating half-life.
"This approval provides people with hemophilia A in
The approval was based on positive results of a Phase 3, prospective, global, multi-center, open label, non-randomized study in patients 12 to 65 years of age with hemophilia A. The study found that previously-treated patients in a twice-weekly prophylaxis arm had a 95 percent reduction in the median overall annualized bleed rate (ABR) compared to those treated on-demand [1.9 vs. 41.5, respectively]. During the study, nearly 40 percent (n=120) of prophylaxis-treated patients experienced zero bleeds.No patients developed inhibitors to the treatment; the most common adverse reactions (≥1 percent of subjects) were headache and nausea.3
Japanese patients (n=11) participated in the pivotal clinical trial where ADYNOVATE demonstrated efficacy in treating hemophilia patients through routine prophylaxis as well as for on-demand bleeding episodes.3
Following approval from the
About ADYNOVATE in
ADYNOVATE is built on the full-length ADVATE molecule, a leading
treatment for hemophilia A that has been used by patients worldwide for
more than 12 years. Through a collaboration with
Indications:
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
CONTRAINDICATIONS
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
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.
Neutralizing Antibodies
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.
ADVERSE REACTIONS
Common adverse reactions (≥1% of subjects) reported in the clinical studies were headache and nausea.
For Full Prescribing Information, visit http://baxalta.com/assets/documents/ADYNOVATE_PI.pdf.
About ADVATE in
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 widely used FVIII treatment. It is currently
approved in 67 countries worldwide, including
Indications:
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.
Detailed Important Risk Information
CONTRAINDICATIONS
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
Hypersensitivity Reactions
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
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.
ADVERSE REACTIONS
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.
For full prescribing information for ADVATE, visit: http://www.baxalta.com/assets/documents/ADVATE_PI.pdf.
About
Forward-Looking Statements
This release includes forward-looking statements concerning
ADYNOVATE, including expectations with regard to regulatory filings.
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
References:
1. Report on the Annual
2. Proprietary pegylation technology exclusively licensed from
3. Konkle, Barbara, et al. Pegylated, full-length, recombinant factor
VIII for prophylactic and on- demand treatment of severe hemophilia A.
Blood.
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