WALTHAM, MA, USA I January 22, 2014 I AMAG Pharmaceuticals, Inc. (AMAG) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme(R) (ferumoxytol) injection for intravenous (IV) use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death. Additionally, the FDA proposed potentially evaluating alternative dosing and/or administration of Feraheme. AMAG is assessing the content and recommendations of the letter and plans further discussions with the FDA.
“We continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA, who have failed or could not tolerate oral iron,” said Steve Caffe, M.D., chief development and regulatory officer of AMAG Pharmaceuticals. “In the coming weeks, we intend to work with the FDA to determine the best regulatory path for Feraheme in this broader IDA patient population.”
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 7:30 a.m. ET, during which management will discuss the complete response letter. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 9:30 a.m. ET on January 22, 2014 through midnight February 22, 2014. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 43512081.
The call will be webcast and accessible through the Investors section of the company’s website at www.amagpharma.com. The webcast replay will be available from approximately 10:30 a.m. ET on January 22, 2014 through midnight February 22, 2014.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme(R) (ferumoxytol) Injection and MuGard(R) Mucoadhesive Oral Wound Rinse in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. 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(R) (ferumoxytol)/Rienso
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have failed oral iron therapy. Feraheme received marketing approval from the U.S. Food and Drug Administration (FDA) on June 30, 2009 for the treatment of IDA in adult chronic kidney disease patients and was commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by five issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book. These patents are set to expire in 2020; a request for patent term extension has been filed, which, if granted, may extend the patent term to 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso.
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.
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 conducted as part of the CKD development program, serious hypersensitivity reactions werereported 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 of Feraheme. In clinical studies conducted as part of the CKD development program, 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.
In clinical trials of patients with IDA and CKD, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients (reported in >= 2% of 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 these 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.
SOURCE: AMAG Pharmaceuticals
Post Views: 34
WALTHAM, MA, USA I January 22, 2014 I AMAG Pharmaceuticals, Inc. (AMAG) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme(R) (ferumoxytol) injection for intravenous (IV) use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death. Additionally, the FDA proposed potentially evaluating alternative dosing and/or administration of Feraheme. AMAG is assessing the content and recommendations of the letter and plans further discussions with the FDA.
“We continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA, who have failed or could not tolerate oral iron,” said Steve Caffe, M.D., chief development and regulatory officer of AMAG Pharmaceuticals. “In the coming weeks, we intend to work with the FDA to determine the best regulatory path for Feraheme in this broader IDA patient population.”
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 7:30 a.m. ET, during which management will discuss the complete response letter. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 9:30 a.m. ET on January 22, 2014 through midnight February 22, 2014. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 43512081.
The call will be webcast and accessible through the Investors section of the company’s website at www.amagpharma.com. The webcast replay will be available from approximately 10:30 a.m. ET on January 22, 2014 through midnight February 22, 2014.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme(R) (ferumoxytol) Injection and MuGard(R) Mucoadhesive Oral Wound Rinse in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. 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(R) (ferumoxytol)/Rienso
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have failed oral iron therapy. Feraheme received marketing approval from the U.S. Food and Drug Administration (FDA) on June 30, 2009 for the treatment of IDA in adult chronic kidney disease patients and was commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by five issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book. These patents are set to expire in 2020; a request for patent term extension has been filed, which, if granted, may extend the patent term to 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso.
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.
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 conducted as part of the CKD development program, serious hypersensitivity reactions werereported 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 of Feraheme. In clinical studies conducted as part of the CKD development program, 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.
In clinical trials of patients with IDA and CKD, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients (reported in >= 2% of 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 these 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.
SOURCE: AMAG Pharmaceuticals
Post Views: 34
