LEXINGTON, MA, USA I June 7, 2013 I AMAG Pharmaceuticals, Inc. (AMAG) today announced that its European commercial partner, Takeda Pharmaceutical Company Limited, has submitted a type-II variation to the European Medicines Agency (EMA) for Rienso(R) (ferumoxytol). The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.
“The filing of the type-II variation for the broad IDA indication for Rienso marks an important corporate milestone for AMAG,” said William Heiden, president and chief executive officer of AMAG. “If approved for this indication, we believe that Rienso could provide a new treatment option for iron deficiency anemia patients who cannot tolerate or do not respond to oral iron therapy.”
The EMA submission is comprised of data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom either did not achieve satisfactory results from or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the phase III studies, IDA-301 (placebo comparator) and IDA-302 (active comparator). Patients enrolled in IDA-301 were also eligible to participate in IDA-303, an extension study to evaluate repeat dosing with ferumoxytol. The data from these studies have previously been reported (see AMAG press releases dated December 10, 2012 and March 15, 2013 for more information).
“As part of Takeda‘s mission to discover and develop innovative solutions addressing the unmet medical needs of patients, we are pleased to be able to be able to work in partnership with AMAG to seek to extend the use of Rienso to provide greater patient benefit,” said Stuart Dollow, managing director of Takeda Global Research and Development Centre (Europe) Ltd.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme(R) in the United States. Along with driving organic growth of its lead product, AMAG intends to expand its portfolio with additional commercial-stage specialty pharmaceuticals. The company is seeking complementary products that leverage the company’s commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com.
About Feraheme (ferumoxytol)/Rienso
In the United States, Feraheme(R) (ferumoxytol) Injection for IV use is indicated for the treatment of iron deficiency anemia in adult CKD patients. Feraheme received marketing approval from the FDA on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme(R), and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso(R). For additional product information, please visit www.feraheme.com.
The important safety information below is based on the United States prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.
Warnings and precautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in >= 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.
SOURCE: AMAG Pharmaceuticals
Post Views: 144
LEXINGTON, MA, USA I June 7, 2013 I AMAG Pharmaceuticals, Inc. (AMAG) today announced that its European commercial partner, Takeda Pharmaceutical Company Limited, has submitted a type-II variation to the European Medicines Agency (EMA) for Rienso(R) (ferumoxytol). The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.
“The filing of the type-II variation for the broad IDA indication for Rienso marks an important corporate milestone for AMAG,” said William Heiden, president and chief executive officer of AMAG. “If approved for this indication, we believe that Rienso could provide a new treatment option for iron deficiency anemia patients who cannot tolerate or do not respond to oral iron therapy.”
The EMA submission is comprised of data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom either did not achieve satisfactory results from or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the phase III studies, IDA-301 (placebo comparator) and IDA-302 (active comparator). Patients enrolled in IDA-301 were also eligible to participate in IDA-303, an extension study to evaluate repeat dosing with ferumoxytol. The data from these studies have previously been reported (see AMAG press releases dated December 10, 2012 and March 15, 2013 for more information).
“As part of Takeda‘s mission to discover and develop innovative solutions addressing the unmet medical needs of patients, we are pleased to be able to be able to work in partnership with AMAG to seek to extend the use of Rienso to provide greater patient benefit,” said Stuart Dollow, managing director of Takeda Global Research and Development Centre (Europe) Ltd.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme(R) in the United States. Along with driving organic growth of its lead product, AMAG intends to expand its portfolio with additional commercial-stage specialty pharmaceuticals. The company is seeking complementary products that leverage the company’s commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com.
About Feraheme (ferumoxytol)/Rienso
In the United States, Feraheme(R) (ferumoxytol) Injection for IV use is indicated for the treatment of iron deficiency anemia in adult CKD patients. Feraheme received marketing approval from the FDA on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme(R), and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso(R). For additional product information, please visit www.feraheme.com.
The important safety information below is based on the United States prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.
Warnings and precautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in >= 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.
SOURCE: AMAG Pharmaceuticals
Post Views: 144
