Panel’s vote a win for Amgen
In a major reprieve for Amgen Inc., an FDA advisory panel decided Tuesday not to recommend strict limits on doses of the company’s anemia medicines for kidney disease and dialysis patients.
After a daylong meeting in Maryland during which outside experts and Amgen representatives made presentations to the panel, its 19 members voted to recommend that the Food and Drug Administration not restrict what doses of the drugs doctors prescribed for patients.
The drugs, which are sold under the brand names Aranesp and Epogen, treat anemia by boosting red blood cell production and raising hemoglobin levels. A similar product, Procrit, is sold by Johnson & Johnson.
The medications are often prescribed for chemotherapy patients and patients with kidney failure. The drugs are major moneymakers for Thousand Oaks-based Amgen, accounting for 50% of its sales last year. Because Johnson & Johnson is more diversified, sales of its drug have a less significant effect on the company’s fortunes.
In recent months, federal regulators have said they are considering whether the labels that spell out prescribing rules for the drugs should be more restrictive by setting targeted caps on hemoglobin levels. Such a move could reduce the drugs’ sales considerably.
The increased scrutiny followed several studies over the last year that raised concerns that the drugs could increase the risk of heart problems and hasten death in some patients.
People without anemia normally have hemoglobin levels of 13 to 18 grams per deciliter of blood. Research has shown that using drugs to keep anemic patients’ hemoglobin levels around 10 grams per deciliter enables the blood to carry enough oxygen for the patient to avoid a transfusion.
But there has been relatively little research into whether using drugs to achieve higher hemoglobin levels is beneficial and safe.
Although the panel’s vote is nonbinding, the FDA typically follows the guidance of such recommendations.
“It appears the agency is going to take a less restrictive view of the drugs on a new label,” said Dr. Elaine Kamil, a nephrologist at Cedars-Sinai Medical Center.
Earlier this year, the FDA placed a so-called black-box warning on the class of drugs.
However, the agency didn’t provide more specific advice on what hemoglobin range doctors should aim for in anemic patients and said it was waiting until Tuesday’s hearing to begin finalizing any such decision. The agency is expected to release a final label in the next few weeks.
Separately, Medicare in July lowered the maximum dose for which it would provide reimbursement.
Amgen is appealing Medicare’s decision and has criticized it as “incompatible with good clinical practice.” When the firm last month announced plans to cut its workforce as much as 14%, it blamed the move partially on the Medicare decision.
At Tuesday’s hearing, Paul Eisenberg, Amgen’s vice president of global regulatory affairs and safety, said the company supported a label targeting a hemoglobin range of 10 grams to 12 grams per deciliter.
Although some panel experts advocated for a cutoff of 11 grams, the majority seemed to agree that the wider range would be better for patients.
The panel also discussed but didn’t act on questions surrounding what to do about patients known as hypo-responders, who don’t show much improvement when given lower doses of the drugs.
Regulators have questioned whether such patients, who account for up to 20% of all patients prescribed these medications, might be “at an increased risk for serious cardiovascular events.”
“The lack of consensus on the panel on some of these issues reflects a lack of consensus in the field at this time,” said Dr. Ajay Singh, a nephrologist and associate professor of medicine at Harvard Medical School who has conducted research in the area.
The FDA panel’s hearing came just a week after a trial with high stakes for Amgen got underway in Boston. In that case, Amgen hopes to block a competitor’s effort to have Amgen’s patents on its anemia drugs voided. A verdict is expected by early October.
Meanwhile, Novartis’ Sandoz unit announced this week that it planned to launch a generic version of Amgen’s Epogen in Europe in the coming weeks.
The product, named Hexal, is expected to sell for about one-third less than Epogen.
Amgen’s stock rose $2.93, or 5.7%, to close at $53.97. Johnson & Johnson’s stock rose 21 cents, or 0.34%, to $62.05.
--
