WASHINGTON (AP) — The FDA said Tuesday 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.
Affymax Inc. is based in Palo Alto, Calif. The company’s shares rose 58 cents, or 4.2.percent, to close at $14.31.