NEW YORK, June 30 (Reuters) - AMAG Pharmaceuticals Inc said on Tuesday U.S. regulators have approved its
injectable anemia medicine Feraheme and that it will be made
available to patients by the second half of July, lifting
shares of the tiny company by 5 percent after hours.
AMAG said the U.S. Food and Drug Administration had approved the drug as an iron replacement therapy in adults with iron deficiency anemia that have chronic kidney disease.
The company said Feraheme, which needs to be given far less frequently than existing iron replacement drugs, could widen treatment to far more patients and likely garner blockbuster sales.
'Feraheme offers patients across the continuum of chronic kidney disease, including patients not on dialysis and patients on dialysis, a new paradigm for the treatment of iron deficiency anemia,' the company said in a release.
'It would be a shame if this drug didn't reach a billion dollar (annual sales) potential in fairly short order because there are tens of millions of patients worldwide who have iron deficiency anemia and this offers an attractive treatment option and literally a cure,' Chief Executive Brian Pereira said in an interview after learning of the FDA approval.
'We think this will change patients' lives,' Pereira said.
Pereira noted the FDA did not impose any unexpected restrictions or requirements on usage of the drug. 'We are delighted. It's rare in life that you can say you got everything you hoped for, and we did.'
The FDA approved Feraheme based on favorable safety and efficacy data from four late-stage studies of patients with chronic kidney disease and iron deficiency anemia. The drug significantly boosted hemoglobin levels, compared with oral iron replacement drugs, AMAG said.
The Lexington, Massachusetts-based company said it plans to begin two small trials next year of Feraheme among pediatric patients with chronic kidney disease. One will be in patients on dialysis, a blood-cleansing procedure needed by patients with advanced kidney disease, and the other in patients not on dialysis.
Company shares were up 5.5 percent at $57.70 after hours from their Nasdaq closing price on Tuesday of $54.67.
(Reporting by Ransdell Pierson and Bill Berkrot, editing by Matthew Lewis) Keywords: AMAG/ (ransdell.pierson@thomsonreuters.com; + 1 646 223-6034; Reuters Messaging: ransdell.pierson.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
AMAG said the U.S. Food and Drug Administration had approved the drug as an iron replacement therapy in adults with iron deficiency anemia that have chronic kidney disease.
The company said Feraheme, which needs to be given far less frequently than existing iron replacement drugs, could widen treatment to far more patients and likely garner blockbuster sales.
'Feraheme offers patients across the continuum of chronic kidney disease, including patients not on dialysis and patients on dialysis, a new paradigm for the treatment of iron deficiency anemia,' the company said in a release.
'It would be a shame if this drug didn't reach a billion dollar (annual sales) potential in fairly short order because there are tens of millions of patients worldwide who have iron deficiency anemia and this offers an attractive treatment option and literally a cure,' Chief Executive Brian Pereira said in an interview after learning of the FDA approval.
'We think this will change patients' lives,' Pereira said.
Pereira noted the FDA did not impose any unexpected restrictions or requirements on usage of the drug. 'We are delighted. It's rare in life that you can say you got everything you hoped for, and we did.'
The FDA approved Feraheme based on favorable safety and efficacy data from four late-stage studies of patients with chronic kidney disease and iron deficiency anemia. The drug significantly boosted hemoglobin levels, compared with oral iron replacement drugs, AMAG said.
The Lexington, Massachusetts-based company said it plans to begin two small trials next year of Feraheme among pediatric patients with chronic kidney disease. One will be in patients on dialysis, a blood-cleansing procedure needed by patients with advanced kidney disease, and the other in patients not on dialysis.
Company shares were up 5.5 percent at $57.70 after hours from their Nasdaq closing price on Tuesday of $54.67.
(Reporting by Ransdell Pierson and Bill Berkrot, editing by Matthew Lewis) Keywords: AMAG/ (ransdell.pierson@thomsonreuters.com; + 1 646 223-6034; Reuters Messaging: ransdell.pierson.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.