Amag Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected its application for wider use of its iron deficiency drug due to safety concerns and asked for more trial data, sending its shares down as much as 15 percent.
In a "complete response letter" to Amag, the FDA suggested that the company generate additional safety data for the wider patient population and evaluate the dosing or administration of the drug, Feraheme.
"The FDA did propose that the company conduct additional trials," Amag Chief Executive William Heiden told Reuters.
"We do have existing safety data from our two large late-stage trials ... certainly we would look to that data to support the safety profile of Feraheme."
The FDA asked Amag to provide additional safety data related to serious hypersensitivity, cardiovascular events and deaths.
Heiden said conducting a new study with safety as the main goal would be easier than conducting an efficacy study, adding that Amag could begin a trial this year, if it came to an agreement with the FDA.
"The treatment period is fairly short and there's a fairly short followup," he said. "The size of the trial and enrolment would be the determining factor on how long the trial would run."
This is not the first time Amag has faced problems related to Feraheme, which is marketed as Rienso in Europe.
Last May, one of Amag's partners, Takeda Pharmaceutical Co Ltd, recalled a batch of Rienso because of a death and several cases of hypersensitivity.
In one of the late-stage trials conducted for the drug's wider approval, Amag reported three deaths, of which two were in the Feraheme-controlled group, but none related to the drug.
The regulator said the company had not provided enough information for the FDA to label the drug as safe for use in patients with adult iron deficiency anemia (IDA) who have failed or cannot tolerate oral iron treatment.
The drug, Feraheme, is already approved to treat iron deficiency anemia in adult chronic kidney disease patients.
Amag's shares were down about 8 percent at $20.14 in morning trading on the Nasdaq.
(Reporting By Vrinda Manocha in Bangalore; Editing by Saumyadeb Chakrabarty and Rodney Joyce)
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