A US regulatory advisory panel has recommended further restrictions on the use of Amgen and Johnson & Johnson’s anaemia drugs in cancer patients but the news could have been worse for the drugmakers.
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee has recommended, by a vote of 9-5, that erythropoiesis-stimulating agents, notably Amgen’s Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), plus J&J’s Procrit (also epoetin alfa), should not be used in patients with metastatic breast cancer or cancer of the head and neck. The panellists also voted 11 to 2 that the anaemia drugs should not be used in patients with cancer who have a curative disease.
However the ODAC decided 13-1 that Amgen and J&J should continue to market the drugs, which are also used to treat patients with chronic kidney disease, for other cancers. John Jenkins, director of the FDA’s Office of New Drugs, said that although the panel was concerned about the risks involved with the ESAs, “we got a clear message that the drugs should still be around”.
Amgen responded by saying that it takes very seriously “the safety signals seen in recent trials where ESAs were used outside of the labelled indication.” The firm added that it is “committed to working with the FDA to consider the input from the committee and to implement future label changes”.
J&J unhappy with recommendation
J&J seemed somewhat more annoyed, however, and its Ortho Biotech unit issued a statement saying that it is concerned by the ODAC’s recommendations. The firm noted that the FDA has not yet reviewed new or follow-up survival data accounting for approximately 50% of the 7,444 patients in the company’s database and out of 59 controlled studies with survival data, “the FDA has focused on eight studies of concern”. All eight researched investigational uses of the drug, at unusually high doses, and the Procrit label “contains specific warnings against such uses”, it said.
R&D president Jay Siegel added that over the past several months, the company provided the FDA with “substantial new data that give important insight into the safety of ESAs. We hope that the FDA will now take time to review this substantial body of data before reaching its final decision.” However the agency usually follows the recommendations of its panels.
If that happens, sales of the ESAs will be hit hard and Aranesp revenues in the USA already fell 22% to $2.15 billion last year amid data which suggested that the drug was linked to a greater risks of heart attacks, stroke and death at high doses, and Medicaid announced a cut in reimbursement rates on the treatment. Procrit’s US sales fell 18% in 2007 to $1.69 billion.
Nevertheless, some observers on Wall Street had feared that the FDA panel would impose a full ban on the drugs and Amgen’s stock actually closed up 4.9% to $47.18. J&J is nowhere near as reliant on its ESA than Amgen and its shares sneaked up 0.4% to $62.81.
