FDA Approves Peginesatide For Anemia.

On the front of its Business Day section, the New York Times  (3/28, B1, Pollack, Subscription Publication) reports, "The Food and Drug Administration on Tuesday approved" peginesatide [Omontys] "for use in increasing red blood cell levels in anemic patients receiving kidney dialysis." The new medication, "developed by a small company called Affymax, works the same way in the body as Amgen's anemia drugs do," but "it is different enough chemically that it is expected to avoid the patent infringement lawsuits that Amgen has wielded successfully to defend its turf." Additionally, peginesatide "could provide a less expensive alternative for dialysis providers and for Medicare, which pays for most dialysis, even for those under 65 years old."

        "The medicines are part of a class of drugs known as erythropoiesis-stimulating agents that boost production of red blood cells," Bloomberg News  (3/28, Edney) reports. "The FDA recommended in June that doctors use the lowest possible doses of the agents because of potential heart risks."

        The Los Angeles Business Journal  (3/28, Crowe) reports, "Omontys is injected monthly, which gives it an advantage over Amgen's anemia drug for chronic kidney disease, epoetin alfa [Epogen], which generally is administered three times a week." In a statement, Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research, said the drug "offers patients and health care providers the convenience of receiving (anemia) therapy just once per month instead of more frequent injections."

        MedPage Today  (3/28, Petrochko) reports, "The most common adverse events observed in 10% or more of dialysis patients with peginesatide included diarrhea, vomiting, hypertension, and arthralgia." According to a FDA statement, "the drug should not be administered to patients who are not receiving dialysis or to patients with cancer-related anemia," and "it should not be used in place of red blood cell transfusion in patients requiring immediate correction to anemia." The drug "was approved with a risk evaluation and mitigation strategy that includes educational elements for healthcare professionals and a requirement to assess drug use data." Also covering the story is the Wall Street Journal  (3/28, Dooren, Subscription Publication).