WASHINGTON (AP) -- The Food and Drug Administration said that it has
approved the first new anemia drug in more than a decade.
The injectable drug Omontys, from Affymax Inc., requires a monthly
injection, giving it a potential advantage over older anemia drugs that are
injected weekly or even more frequently. Regulators approved the drug for adult
dialysis patients with anemia caused by chronic kidney disease. Older anemia
drugs are also used to treat patients with anemia caused by chemotherapy.
Omontys joins a trio of drugs that treat anemia by boosting formation of
hemoglobin, a protein in red blood cells that deliver oxygen throughout the
body. Drugs already on the market include Aranesp and Epogen, sold by Amgen
Inc., and Procrit, sold by Johnson & Johnson. Doctors prescribe the drugs
to reduce the need for painful blood transfusions in people with anemia, a
blood disorder that causes weakness and shortness of breath.
The drugs are multibillion-dollar sellers and had combined U.S. sales of
$6.1 billion last year, according to health care data firm IMS Health. Sales
have fallen sharply since 2007, when the FDA added the first of several safety
warnings to the drugs, based on evidence that they can encourage tumor growth
and hasten death in cancer patients. The drugs are no longer used in patients
with several types of cancers.
In 2006 anemia drugs had sales of $9.8 billion in the U.S.
The new drug will be distributed to patients with an educational pamphlet
detailing potential adverse events. The most frequent side effects from the
drug include diarrhea, vomiting and high blood pressure.
About
Affymax Inc.
Affymax Inc. is based in Palo Alto, Calif. The company's shares rose 58
cents, or 4.2.percent, to close at $14.31.