WASHINGTON (Reuters) - U.S. health regulators want advisers’ input on the risks of blockbuster anemia drugs sold by Amgen Inc and Johnson & Johnson in certain chronic kidney disease patients, including how to adjust dosing and possible label changes.
Food and Drug Administration staff, in a document released on Thursday, said they agreed with Amgen that its recent TREAT trial failed to show anticipated benefits of its drug, Aranesp, in patients not yet on dialysis. The trial also showed a higher risk of stroke and death in those who had a history of cancer.
While such drugs, known as erythropoiesis-stimulating agents or ESAs, still rake in billions, their sales have fallen off in recent years after concerns emerged that doctors may be overusing the drugs in certain patients.
FDA released its review ahead of a public meeting set for Monday to discuss the safety issues in the wake of the trial’s findings. Roger Perlmutter, Amgen’s executive vice president of research and development, said the drugmaker has already proposed label changes aimed at reducing Aranesp’s use.
“We’re concerned, and we don’t want to see these drugs overused,” Perlmutter said.
It is the latest in a years-long saga over concerns with the red blood cell-stimulating drugs and their use in kidney disease and cancer patients. The drugs help treat anemia that arises from kidney malfunction or as a side effect of chemotherapy.
Amgen also makes Epogen, a shorter-lasting version of Aranesp used in kidney patients who are undergoing dialysis. It licensed Epogen in part to Johnson & Johnson, which sells it in the United States under the brand Procrit for predialysis and cancer patients to compete with Aranesp.
At issue is just how high a patient’s hemoglobin level should be. For years, many doctors thought high levels of the protein, which transports oxygen in the body, was beneficial. But recent data has shown that it can cause numerous problems.
Amgen, in a separate document also released on Thursday, said it was seeking three specific label changes to limit use of the drug in non-dialysis patients, to maintain hemoglobin levels at between 10 and 12 grams per deciliter, and to limit the drug in those who do not respond.
On Monday, FDA plans to ask its panel of outside advisers to weigh in on the risks and benefits of using the drugs in kidney disease patients who are not on dialysis.
Sales of ESAs have sharply declined since safety concerns emerged but are still expected to see $4.5 billion in 2010.
Earlier this year, FDA set new guidelines about use of ESAs in cancer patients. In 2007, the nation’s insurance programs for the elderly, disabled and poor — Medicare and Medicaid — changed their payment policy in an attempt to curb unnecessary use of the drugs in cancer patients and reduce risks.
The Centers for Medicare and Medicaid Services, which oversees the programs, has already changed its payments for more serious kidney patients to curb use and is considering changes for nondialysis patients.
Aranesp saw global sales of $4.1 billion in 2006 and is expected to see $2.5 billion in 2010, according to Thomson Reuters data. Sales of J&J’s drug saw $3.2 billion in 2006 and are expected to reach $2 billion this year, the data showed.
Amgen’s Perlmutter said use of its drug in kidney patients has further declined since its TREAT data came out in 2009 and that doctors have taken steps to use ESAs more appropriately.
“We do not expect it to dramatically change practice,” he said.
Still, regulators are weighing in, although it is unclear when they will make any final rulings. Analysts say government closure on the issue will help the companies move forward.
“While there isn’t much upside potential from the (FDA) panel, a benign discussion would remove a risk to Amgen’s core ESA franchise going forward,” J.P. Morgan analysts have said.
Monday’s FDA meeting comes roughly one year after Amgen’s data was made public, and CMS has made no announcements since its meeting on the issue in March.
The agency plans to ask about possible dosing changes and label changes to address safety concerns, its staff said.
FDA will weigh its panel’s recommendations before making any final decision. CMS is also likely to consider the FDA’s decision in making any payment changes.
Amgen shares were down 1.42 percent and J&J shares were little changed on Thursday afternoon.
Reporting by Susan Heavey; Additional reporting by Deena Beasley in Los Angeles; Editing by Maureen Bavdek and Matthew Lewis