FDA approves Amag anemia drug
Lexington drug maker Amag Pharmaceuticals Inc. said yesterday it has won approval for an iron replacement therapy with the potential to be its first blockbuster drug.
The company said the Food and Drug Administration granted long-delayed approval to market its Feraheme injection for intravenous use in the treatment of iron deficiency anemia in adults with chronic kidney disease. The FDA has approved fewer than two dozen new drugs annually in recent years.
Brian J.G. Pereira, president and chief executive of Amag, said in an interview that the approval represents the biggest milestone in the company’s 28-year history. It has produced and stockpiled the therapy in anticipation of the FDA’s decision.
“This has the potential to be a billion dollar drug that offers a treatment for iron deficiency anemia, which is one of the most common medical conditions worldwide,’’ said Pereira, a nephrologist by training who worked with kidney disease patients at Tufts Medical Center before joining Amag 3 1/2 years ago.
Amag made the announcement after the stock markets closed, but in after-hours trading, the company’s shares advanced $2.21 to $56.80, a gain of more than 4 percent, on the Nasdaq exchange.
Eric Varma, biotechnology analyst for Leerink Swann LLC, a healthcare investment bank in Boston, projected Feraheme will reach annual sales of $300 million by 2013. Whether sales can grow further to reach the company’s goal of $1 billion a year will partly depend on whether it gains “off-label’’ approval to treat other classes of patients with chemotherapy-induced anemia and postpartum anemia, Varma said.
The company is limited to marketing Feraheme to treat patients with chronic kidney disease, both those on dialysis and those not on dialysis. It was the first intravenous iron therapy approved in nearly a decade. While doctors will be allowed to prescribe it for other anemia patients, the company won’t be able to market the drug for other types of anemia without further approvals.
“We believe Feraheme will be priced at a premium to other drugs like Venofer,’’ said Varma, referring to a rival iron deficiency treatment made by Luitpold Pharmaceuticals Inc. of Shirley, N.Y., that sells for $350 to $400 per dose. “Feraheme could potentially replace Venofer in the short term because it allows dialysis centers to give patients fewer doses and faster doses,’’ he said.
Amag said in a statement that it expects Feraheme to be commercially available in the United States later this month. An 80-person sales force will market the drug to nephrologists, wholesalers, and specialty distributors.
Pereira said he has built up staff in recent months in anticipation of the drug going to market. The company, formerly called Advanced Magnetics Inc., now has about 260 employees, including 150 in Massachusetts. It moved its headquarters from Cambridge to Lexington last year, but still has a manufacturing site in Cambridge.
In addition to its iron replenishment drug, Amag makes imaging agents used to aid in the diagnosis of cancer and cardiovascular disease.
Robert Weisman can be reached at weisman@globe.com. 