Daiichi Drug Backed With Restrictions by U.S. Panel
Daiichi Sankyo Co.s drug Injectafer
should be sold in the U.S. as a backup treatment for iron
deficiency anemia, a panel of U.S. advisers recommended, even
though regulators had expressed concern about safety risks.
The drug, given intravenously, should be used only when
oral medications dont work or cant be tolerated, a Food and
Drug Administration advisory panel said in a 10-5 vote today at
a meeting in Silver Spring, Maryland.
Daiichi wants to market Injectafer for iron deficiency
anemia in women after childbirth and those with heavy uterine
bleeding. The company proposed selling the medication as a
primary treatment. The drug was linked in studies to more deaths
than comparable treatments, raising “significant safety
concerns, FDA staff wrote in a document that was posted this
week on the agencys Web site.
“Theres a signal that the drug might increase the risk of
death, said Sean Hennessy, the panels chairman and a
professor of epidemiology at the University of Pennsylvania
School of Medicine in Philadelphia, in an interview after the
vote. “While its only a signal, you want to take it
seriously.
The risk of death “may be outweighed by the benefit of
the drug, he said. Many women suffer nausea and constipation
from iron pills and Injectafer may be a good alternative, panel
members said.
The agency usually follows the advice of its advisory
panels, although it isnt required to do so. The FDA is expected
to make a decision by mid-March, the company said.
The treatment is approved for sale in Europe under the name
Ferinject. Swiss drugmaker Galenica AG licensed the U.S. version
to Tokyo-based Daiichi.
Daiichi fell 60 yen, or 1.9 percent, to 3,130 in Tokyo
trading before the meeting. Galenica rose 17 Swiss francs, or
4.7 percent, to 382 in Zurich trading. The company fell 17
percent, the most since at least 1989, after the FDA staff
report was released on Jan. 30.
3 Million Women
About 3 million women of childbearing age in the U.S. have
been diagnosed with iron deficiency anemia, according to
Daiichi. The condition, in which the number of red blood cells
is abnormally low, can result from bleeding, according to the
National Institutes of Health.
The company is pleased with the panels discussion, even
though the advisers endorsed a more restrictive use, said Mary
Jane Helenek, president and chief executive officer of Luitpold
Pharmaceuticals, a U.S. unit of Daiichi, in an interview.
“I believe were walking away with a path forward,
Helenek said.
No intravenous drugs are approved for the uses the FDA is
considering for Injectafer, analyst Carol Werther, of Summer
Street Research Partners in Boston, said in an interview.
Patients typically are given over-the-counter iron pills,
said Richard Branda, a professor in the hematology and oncology
division of the University of Vermont in Burlington, in an
interview. On occasion, doctors may use the intravenous drugs
Venofer, sold by Daiichi, and Ferrlecit, sold by Watson
Pharmaceuticals Inc., which are approved for other types of iron
deficiency anemia, he said.
Once drugs are cleared for sale, doctors are free to
prescribe them for uses other than those approved by the FDA,
although companies arent supposed to market the products for
unapproved purposes.
Ten Patients Died
Ten patients died after receiving Injectafer in the
companys studies, according to the FDA. One patient died taking
Venofer, the drug used for comparison. Five of the 10
Injectafer-related deaths stemmed from heart trouble, the FDA
review found.
“None of the deaths were related to Injectafer, said
Walter Tozzi, director of marketing and professional services
for American Regent, a unit of Daiichi, in an interview today.
“The drug is safe.
Daiichi originally applied to sell Injectafer to treat
anemia linked to childbirth, heavy uterine bleeding,
inflammatory bowel disease and dialysis. The FDA rejected the
application on concerns about patient deaths, so the company
submitted a new analysis and revised its proposal in November to
include only women after childbirth or those with heavy uterine
bleeding, according to the agency document.
Amag Pharmaceuticals Inc., based in Cambridge,
Massachusetts, is developing a similar anemia treatment called
ferumoxytol.
