U.S. may restrict anemia drug dose
Amgen Inc. and Johnson & Johnson may have to limit doses of anemia drugs to lower risks for patients, U.S. regulators said Friday. The change would reduce revenue from the top-selling medicines.
The anemia drugs, marketed as Aranesp and Epogen by Amgen and Procrit by J&J;, raised the danger of heart attacks, strokes and death at high doses, staff of the Food and Drug Administration said in an analysis posted on the agency’s website.
A committee of kidney and cardiovascular experts advising the FDA will consider the report and may recommend new restrictions on the medicines when it meets Tuesday.
An FDA warning in March had prompted doctors to cut back on use and led Medicare to put new payment restrictions on the drugs in July. Aranesp’s U.S. sales fell 19% in the second quarter.
“We expect the meeting to be contentious,” said Michael Aberman, an analyst with Credit Suisse in New York, in a note to clients Friday. Four speakers invited to address the panel believe that the drugs have been overused, Aberman said.
The FDA staff said it would seek the panel’s advice on whether to tell doctors to use the anemia drugs to boost patients’ counts of hemoglobin, a protein that carries oxygen in the blood, to a specific level or range. The staff said it would also seek advice on the need for further clinical trials.
“Serious cardiovascular risks have been shown” for patients who took higher-than-recommended doses of the drugs, the FDA staff said.
Studies have found that high doses aren’t the only issue, the report said. Patients who don’t respond well to initial anemia therapy, known as hyporesponders, are exposed to the highest heart risks, the agency said. The drug makers haven’t yet offered information on how to help those patients avoid the risks, according to the FDA staff.
“A lot of investors were nervous going into this panel meeting, and it seems like a justified concern,” said Christopher Raymond, an analyst with Robert W. Baird in Chicago.
Thousand Oaks-based Amgen is the world’s largest biotechnology company. The anemia drugs accounted for $6.6 billion, or almost half of Amgen’s revenue in 2006.
Amgen shares fell $1.11, or 2.1%, to $50.90.
The drop was the biggest since Aug. 16, after the company said it was cutting 2,600 jobs because of declining anemia drug sales.
Johnson & Johnson, based in New Brunswick, N.J., generated $3.18 billion in sales from Procrit in 2006.
J&J; shares rose 2 cents to $61.68.
The anemia drugs are approved to treat patients whose weakness and fatigue are caused by chronic kidney disease or by the side effects of cancer chemotherapy. The medicines stimulate production of oxygen-carrying red blood cells, which can boost patients’ energy and strength.
Debate over the drugs’ safety primarily involves how big a dose to use to boost concentrations of hemoglobin.
Amgen said its review of clinical trials showed that the drugs could reduce the need for blood transfusions and improve quality of life when used within the original dosing range.
The anemia drugs “provide clear clinical benefit” in trials and experience with 4 million patients over 18 years, said Stephanie Fagan, a spokeswoman for Ortho Biotech, the unit of Johnson & Johnson that markets Procrit.
