New hurdles for Amgen anemia drug
Aranesp, biotech giant Amgen Inc.'s once-highflying anemia drug, took another hit Wednesday when the Food and Drug Administration ordered new restrictions on the way physicians prescribe it to cancer patients.
Amgen’s most successful biotech franchise, Aranesp has been under review by U.S. health officials since it was tied to a greater risk of heart attack, stroke and death at high doses in cancer patients nearly two years ago. Anemia is a common side effect from chemotherapy.
The new restrictions also apply to Procrit, an identical product made by Amgen and sold by Johnson & Johnson.
Industry analysts said the news was largely expected and cited a significant reduction in anemia drug sales in the last year. Shares of the Thousand Oaks-based company gained 2 cents to close at $62.30 on Wednesday.
The news came less than a week after Amgen announced that its experimental osteoporosis drug denosumab reduced fractures in a study of women with the bone-thinning disease, causing Amgen’s stock to jump 13% on Monday.
Amgen said it would begin communicating the revised product labeling for the drugs to physicians and patients.
Under the new restrictions, labels must state that the drugs are not intended for patients undergoing chemotherapy. The instructions must also warn that patients using the drugs could have an increased risk of tumor progression or recurrence.
Earlier this year the drugs came under increased scrutiny by federal health officials after studies suggested that the drugs could promote cancer growth in certain patients and accelerate their death. Sales dropped sharply since the FDA added a so-called black box warning to those drugs’ labels more than a year ago.
In March an FDA panel had suggested scaling back which patients should be treated with the anemia drugs based on their type of cancer and the severity of the disease. That led analysts to predict further sales declines.
Analysts said it was too soon to gauge the effect of the new label on sales, but any change was expected to be minimal. The market has already adjusted to the increased scrutiny applied to the anemia drugs, said Les Funtleyder, a Miller Tabak & Co. analyst in New York.
“The stock market, prescribers and payers have already reacted to a lot of this,” Funtleyder said. “There may be some refining of behavior, but not much.”