ADYNOVATE is the only extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on the demonstrated efficacy of ADVATE [Antihemophilic Factor (Recombinant)]. ADYNOVATE was approved by the FDA in November 2015 for use in adolescent and adult hemophilia A patients (12 years and older) for prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding.
"We know there is a great need for innovative new treatments among pediatric patients and during surgery and we look forward to working with the FDA as they review ADYNOVATE for these patients," said Brian Goff, executive vice president and president, Hematology. "We are committed to continually advancing direct factor replacement treatments and specifically to expanding use of ADYNOVATE, providing as many patients as possible access to its proven prophylaxis and simple, twice-weekly dosing schedule."
The submission of ADYNOVATE to treat children under the age of 12 was based on results of a Phase 3 trial designed to assess the efficacy and safety including immunogenicity of ADYNOVATE, which was initially reported in
The filing was also supported by the positive results of a Phase 3 study evaluating the efficacy and safety of ADYNOVATE for the perioperative control of hemostasis among 15 patients with severe hemophilia A undergoing surgical procedures, which was reported in
Baxalta continues to invest in ADYNOVATE to expand the product's value for more patients worldwide. Baxalta plans to file for marketing authorization in Europe in the first quarter of 2016 and expects regulatory approval of the treatment in Japan in the first half of the year. ADYNOVATE is also under regulatory review in Canada and Switzerland.
ADYNOVATE is built on the full-length ADVATE molecule, a leading treatment for hemophilia A that been used by patients worldwide for more than 12 years. Through a collaboration with
About ADYNOVATE
Indications:
ADYNOVATE 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
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 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 Baxalta
Forward-Looking Statements
This release includes forward-looking statements concerning ADYNOVATE, including expectations with regard to regulatory filings 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 Baxalta's control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta's filings with the Securities and
Exchange Commission, all of which are available on
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