ELSTREE, UK & DURHAM, NC, USA I April 13, 2016 I Bio Products Laboratory, Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced the submission of a Biologics License Supplement (BLS) to the U.S. Food and Drug Administration (FDA) for the use of Gammaplex 10%, Immune Globulin Intravenous (Human) in patients with primary immunodeficiencies.
The application is based on a two-phase, crossover bioequivalence study between the 10% immune globulin treatment being investigated and BPL’s approved immunoglobulin treatment, Gammaplex 5%, and was submitted on April 8, 2016. The study marks the first time that a 5% and a 10% immune globulin therapy have been directly compared in a registration trial in patients with primary immunodeficiencies.
“We’re excited by the study results and meeting this submission milestone,” said Eric Wolford, PharmD, Vice President of Global Medical for BPL. “Conducting innovative research to bring patients with primary immunodeficiencies the potential for another therapeutic option required significant effort from BPL researchers and investigative sites.”
Gammaplex 10% is currently under review by the FDA, and not yet available in the US.
Primary immunodeficiencies are a constellation of immune disorders that can negatively impact the body’s ability to fight infection. In some primary immunodeficiencies, the immune system does not manufacture adequate quantities of antibodies such as immune globulin G. Gammaplex 5% is indicated for replacement therapy in patients with primary immunodeficiencies. This indication includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott Aldrich syndrome, and severe combined immunodeficiencies.
About Gammaplex®
Gammaplex® Immune Globulin Intravenous [Human] 5% liquid is indicated for replacement therapy in primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. Gammaplex is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
Gammaplex is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin, a hereditary intolerance to fructose and in infants and neonates for whom sucrose or fructose tolerance has not been established, and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Please see the additional Important Safety Information about Gammaplex set forth below, and the full prescribing information at http://www.gammaplex.com/prescribing-information.html.
Important Safety Information
Thrombosis may occur with immune globulin products, including Gammaplex. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin intravenous (lGIV) products, including Gammaplex. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Gammaplex is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin; a hereditary intolerance to fructose and in infants and neonates for whom sucrose or fructose tolerance has not been established; and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Thrombotic events may occur following treatment with immune globulin products, including Gammaplex. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
In patients at risk of developing acute renal failure, monitor renal function, including blood urea nitrogen (BUN), serum creatinine and urine output. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.
Aseptic meningitis syndrome (AMS) may occur infrequently with IGIV treatment. AMS usually begins within several hours to 2 days following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
Hemolysis and hemolytic anemia can develop subsequent to IGIV treatments. Patient risk factors that may be associated with development of hemolysis include high dose (>2 g/kg), non-O blood group, and underlying inflammatory state.
Noncardiogenic pulmonary edema may occur in patients following IGIV treatment (i.e. transfusion-related acute lung injury [TRALI]). Monitor patients for pulmonary adverse reactions (TRALI). If TRALI is suspected, test product and patient’s serum for anti-neutrophil antibodies.
Gammaplex is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex.
In clinical studies, the most common adverse reactions with Gammaplex were headache, pyrexia, vomiting, fatigue, pain, nausea, hypertension, chills and myalgia. Serious adverse reactions observed in clinical trial subjects with PI were thrombosis and chest pain. Serious ARs observed in clinical trial subjects with ITP were headache, vomiting and dehydration.
About Bio Products Laboratory, Ltd.
Bio Products Laboratory, Limited (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide. The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets Gammaplex in the US and a wide range of products outside the US, including coagulation factors, human immunoglobulins, and albumin. BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high-quality products to patients and healthcare providers worldwide.
SOURCE: Bio Products Laboratory
Post Views: 131
ELSTREE, UK & DURHAM, NC, USA I April 13, 2016 I Bio Products Laboratory, Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced the submission of a Biologics License Supplement (BLS) to the U.S. Food and Drug Administration (FDA) for the use of Gammaplex 10%, Immune Globulin Intravenous (Human) in patients with primary immunodeficiencies.
The application is based on a two-phase, crossover bioequivalence study between the 10% immune globulin treatment being investigated and BPL’s approved immunoglobulin treatment, Gammaplex 5%, and was submitted on April 8, 2016. The study marks the first time that a 5% and a 10% immune globulin therapy have been directly compared in a registration trial in patients with primary immunodeficiencies.
“We’re excited by the study results and meeting this submission milestone,” said Eric Wolford, PharmD, Vice President of Global Medical for BPL. “Conducting innovative research to bring patients with primary immunodeficiencies the potential for another therapeutic option required significant effort from BPL researchers and investigative sites.”
Gammaplex 10% is currently under review by the FDA, and not yet available in the US.
Primary immunodeficiencies are a constellation of immune disorders that can negatively impact the body’s ability to fight infection. In some primary immunodeficiencies, the immune system does not manufacture adequate quantities of antibodies such as immune globulin G. Gammaplex 5% is indicated for replacement therapy in patients with primary immunodeficiencies. This indication includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott Aldrich syndrome, and severe combined immunodeficiencies.
About Gammaplex®
Gammaplex® Immune Globulin Intravenous [Human] 5% liquid is indicated for replacement therapy in primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. Gammaplex is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
Gammaplex is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin, a hereditary intolerance to fructose and in infants and neonates for whom sucrose or fructose tolerance has not been established, and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Please see the additional Important Safety Information about Gammaplex set forth below, and the full prescribing information at http://www.gammaplex.com/prescribing-information.html.
Important Safety Information
Thrombosis may occur with immune globulin products, including Gammaplex. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin intravenous (lGIV) products, including Gammaplex. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Gammaplex is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin; a hereditary intolerance to fructose and in infants and neonates for whom sucrose or fructose tolerance has not been established; and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Thrombotic events may occur following treatment with immune globulin products, including Gammaplex. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
In patients at risk of developing acute renal failure, monitor renal function, including blood urea nitrogen (BUN), serum creatinine and urine output. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.
Aseptic meningitis syndrome (AMS) may occur infrequently with IGIV treatment. AMS usually begins within several hours to 2 days following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
Hemolysis and hemolytic anemia can develop subsequent to IGIV treatments. Patient risk factors that may be associated with development of hemolysis include high dose (>2 g/kg), non-O blood group, and underlying inflammatory state.
Noncardiogenic pulmonary edema may occur in patients following IGIV treatment (i.e. transfusion-related acute lung injury [TRALI]). Monitor patients for pulmonary adverse reactions (TRALI). If TRALI is suspected, test product and patient’s serum for anti-neutrophil antibodies.
Gammaplex is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex.
In clinical studies, the most common adverse reactions with Gammaplex were headache, pyrexia, vomiting, fatigue, pain, nausea, hypertension, chills and myalgia. Serious adverse reactions observed in clinical trial subjects with PI were thrombosis and chest pain. Serious ARs observed in clinical trial subjects with ITP were headache, vomiting and dehydration.
About Bio Products Laboratory, Ltd.
Bio Products Laboratory, Limited (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide. The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets Gammaplex in the US and a wide range of products outside the US, including coagulation factors, human immunoglobulins, and albumin. BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high-quality products to patients and healthcare providers worldwide.
SOURCE: Bio Products Laboratory
Post Views: 131
