UPDATE 2-AMAG anemia drug wins US approval, shares jump
* FDA approves drug for iron deficiency anemia
* Company says drug's convenience could widen treatment
* Shares rise 5 pct after hours (Adds CEO quotes, background on anemia drug, bylines)
By Ransdell Pierson and Bill Berkrot
NEW YORK, June 30 (Reuters) - AMAG Pharmaceuticals Inc
(AMAG.O) said U.S. regulators approved its injectable anemia
medicine Feraheme, which will be available to patients by the
second half of July, lifting shares of the tiny company by 5
percent.
AMAG said Tuesday 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 less frequently than existing iron replacement drugs, could widen treatment to far more patients and likely achieve 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 statement.
"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, who added that 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," he said.
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-cleaning procedure needed by patients with advanced kidney disease, and the other in patients not on dialysis.
In an interview earlier this month, Pereira described Feraheme as a simple drug that has immense convenience advantages over current iron therapy. Patients who now require about 10 lengthy infusion sessions to boost iron levels could be treated with Feraheme with two injections that take just 17 seconds to administer, he said.
Feraheme has a special sugar coating to protect blood vessels, Pereira said.
Many anemic kidney patients now receive Amgen Inc's (AMGN.O) Epogen or Johnson & Johnson's (JNJ.N) Procrit, red blood cell boosters that have come under intense scrutiny over safety and overuse concerns. Pereira said Feraheme could help to significantly reduce the needed dosages of those drugs.
Relatively few kidney patients not yet on dialysis are taking iron therapy for their anemia despite fatigue and other effects of the condition due to the extreme inconvenience of infusions, a market Feraheme could break open, Pereira said.
Company shares were up 5 percent at $57.11 in after hours trading from their Nasdaq close of $54.67. (Reporting by Ransdell Pierson and Bill Berkrot, editing by Matthew Lewis and Tim Dobbyn)
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