Xgeva, whose chemical name is denosumab, is approved for use in those suffering from advanced prostate cancer which has moved into the patient’s bones. The drug is approved to help prevent fractures in these patients. It is administered by injection. The drug is manufactured by Amgen, Inc.
Sales of Xgeva have skyrocketed in recent months. In fact, in the first quarter of this year alone, Xgeva sales have risen an astonishing 14 percent. Amgen’s profits from Xgeva were $153 million in that quarter alone. Amgen – and wall street analysts – believe that the drug will soon account for $1 billion a year in sales.
However, last week the Food and Drug Administration (the FDA) rejected Amgen’s request to expand the use of Xgeva to help prevent tumors from spreading into the bones of patients with advanced-stage prostate cancer. The FDA’s refusal was based on a determination that the risks to patients outweigh the benefits.
The principal concern with the use of Xgeva is the possibility of jawbone injuries. Studies have shown that use of the drug can lead to a condition which destroys the jawbone entirely.
The FDA did, however, leave open the possibility that the proposed use of Xgeva will ultimately gain approval. The agency, while denying approval today, also asked for Amgen to provide data from further trials.
Nor is Amgen giving up on expanding Xgeva’s use in other areas. Amgen is currently testing the drug in patients with other forms of cancer, including breast cancer and lung cancer.
Amgen, Inc. is the world’s single largest biotechnology company. Its growth in recent years has been primarily driven by Xgeva and Polia, a drug used to treat osteoporosis. Analysts predict that expanding use of Xgeva and Polia will help Amgen to make up for declining sales of its anemia drugs.
Sadly, the story of Xgeva is not novel to those experienced in pharmaceutical products liability. Drug companies such as Amgen are increasingly driven solely by profits, minimizing or ignoring entirely the health and well-being of the patients they supposedly exist to help. Amgen’s push to expand Xgeva’s use into as many areas as possible, despite known safety concerns, mirrors the actions of numerous other pharmaceutical companies, and will surely be repeated again.
Our experienced products liability attorneys urge the FDA to stand fast against Amgen’s push to expand Xgeva use, and the many similar efforts to unreasonably expand the use of various prescription drugs in the United States. As the manufacturers of these drugs cannot and will not protect the patients they service, the FDA itself must stand in the way of the constant push to subject more and more Americans to these dangerous treatments.
For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500.