“We are pleased to see the consistency of both the safety and efficacy data observed across the full IDA phase III program in studies IDA-301, IDA-302 and now IDA-303,” said William Heiden, president and chief executive officer of AMAG. “The final data from this study will be included in the registration package for ferumoxytol in Europe in pursuit of the broader IDA indication, which we expect will be filed this year.”
In December 2012, AMAG submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) requesting FDA approval to expand the indication for ferumoxytol beyond the current approved indication for the treatment of IDA in adult patients with chronic kidney disease to all adult patients with IDA who have failed or could not tolerate oral iron treatment. This sNDA is currently under review with the FDA. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set October 21, 2013 as a target date for completion of their review.
Conference Call Information
AMAG will host a conference call and webcast at 8:00 a.m. EDT today. 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 11:00 a.m. EDT on March 15, 2013 through midnight March 22, 2013. 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 23976614.The call will be webcast live and accessible through the Investors section of the company’s website at www.amagpharma.com. A replay of the webcast will be available from approximately 11:00 a.m. EDT on March 15, 2013 through midnight April 15, 2013. About Iron Deficiency Anemia More than 4 million Americans have IDA; 1.6 million of whom are estimated to have CKD, while the other 2.4 million suffer from anemia due to other causes. 1 For these patients with anemia due to other causes, the underlying diseases or issues causing IDA include abnormal uterine bleeding, gastrointestinal disorders, inflammatory diseases and chemotherapy-induced anemia. Many IDA patients fail treatment with oral iron due to intolerability or side effects. 2 About AMAG AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® 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 (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter.