Two months after federal regulators ordered additional warnings be added to the labels of blockbuster anemia drugs, government advisers said Thursday Amgen Inc. and Johnson & Johnson should be required to add more warnings and conduct additional safety studies.
The Food and Drug Administration’s outside panel of experts voted overwhelmingly in favor of expanding warnings about the risks of death, blood clots and other side effects for Amgen’s Aranesp and Johnson & Johnson’s Procrit.
Wall Street analysts said prior to the meeting that the biggest threat to the revenue the companies get from these drugs would be if panelists wanted to add warning labels that would limit prescribing the drugs to certain patients.
A drop in anemia drug sales would pose a much larger challenge to biotech maker Amgen than to diversified competitor Johnson & Johnson. Last year Aranesp was Amgen’s best-selling product with sales of $4.1 billion, or nearly 30 percent of full-year revenue. When combined with Epogen, a version of the drug used only in kidney failure patients on dialysis, the medication accounts for more than half of Amgen’s annual sales.
The panel of experts, at a meeting in a hotel here, also voted unanimously that the companies should be required to conduct new studies to definitively prove the safety of the two widely prescribed drugs. Anemia drugs accounted for $10 billion in revenue for these two companies last year alone.
The FDA is not required to follow the panel’s recommendations although it typically does.
Johnson & Johnson and Amgen have conducted more than a dozen studies of the drugs to date although panelists Thursday said what is needed is a large, comprehensive study of whether people who take the drugs die sooner than those who don’t.
In March, the FDA ordered warnings be added to the drugs’ labels after recent studies showed using the drugs outside of approved guidelines could increase the growth of tumors and the risk of death in some patients.
It was not made clear during Thursday’s meeting whether the additional warnings favored by panelists would apply to all uses of the drugs or just non-approved use.
Many physicians prescribe anemia drugs aggressively to raise their patients’ red blood cell levels to that of a healthy person, believing the higher red blood cell levels improves quality of life.
In presentations to the panel Thursday, FDA staff focused on four studies suggesting overprescribing or prescribing for unapproved uses could in fact increase a patient’s risk of death.
Still, a majority of panelists voted against requesting that product packaging be changed to recommended lower dosing levels.
“We will be working with the FDA as they consider the committee’s recommendations,” said Amgen spokeswoman Tricia Hawkins.
A spokeswoman for Johnson & Johnson stressed that the company has not seen negative side effects from its drug when used as directed.
“When used according to the label, Procrit is safe and effective, and has an acceptable risk-benefit profile,” said J&J’s Stephanie Fagan.
Aranesp and Procrit are man-made versions of a naturally occurring protein that increases production of red blood cells. The drugs are approved to treat the blood disorder anemia when it is caused by chemotherapy and kidney disease.
FDA’s meeting did not address use of the drugs in kidney patients. The agency said it would hold a seperate meeting on that issue in the fall.
Aftershocks from the newest recommendations could be felt later this year as the Center for Medicare and Medicaid Services reconsiders when and how much it pays for anemia drugs. The agency, which provides health care to more than 80 million Americans, has said it will use FDA’s analysis of the drugs’ safety in its reassessment.
Medicare officials have already told local plan providers they can stop paying for Aranesp and Procrit when used in cancer patients who are not on chemotherapy because that use is not government approved. Amgen said last month that action alone would probably cost the company $500 million in sales this year.
While it’s difficult to predict what additional payment changes might be made, analysts worry the agency could stop paying for the drugs under certain circumstances. Medicare officials are scheduled to release preliminary guidelines in September.