Enbrel “Black Box” Under Consideration By FDA, Amgen Execs Say
This article was originally published in The Pink Sheet Daily
Executive Summary
Amgen also has received two federal subpoenas related to its products, the firm discloses.
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FDA may require that a "black box" warning be added to labeling for the tumor necrosis factor inhibitor Enbrel (etanercept), in line with other agents in the class, Amgen Senior VP-North America Commercial Operations James Daly said during a Nov. 13 meeting with Amgen management hosted by Bear Stearns. "It's probably not useful to speculate in terms of what the label may or may not look like," Daly said, adding, "There is a range of outputs up to and including a black box." While FDA may require heightened emphasis on safety information associated with the rheumatoid arthritis treatment, the update is not based on new data, he maintained. "In terms of how the market will react, there's no new clinical data out there that impacts the risk/benefit ratio," the exec said. "So we don't think the label change in the absence of compelling new data will fundamentally change the risk/benefit profile of the drug." Amgen disclosed in a 10-Q filing with the Securities and Exchange Commission Nov. 9 that it is in discussions with FDA regarding an updated label for Enbrel. Labeling for the biologic currently includes a bolded warning related to post-marketing reports of serious infections and sepsis, including death, as well as rare cases of tuberculosis associated with Enbrel. Other anti-TNFs already carry a black box warning. They include Johnson & Johnson's Remicade (infliximab), which added language in 2006 regarding post-marketing reports of hepatosplenic T-cell lymphoma in adolescent patients treated with Remicade to an existing boxed warning for risk of TB (1 (Also see "Remicade “Black Box” Warning On Risk Of Lymphoma Added To Label" - Pink Sheet, 19 May, 2006.)). Abbott's Humira (adalimuab) similarly carries a black box warning for risk of TB and opportunistic infections. Also in the 10-Q filing, Amgen reported that it has received two federal subpoenas related to its products, although the Thousand Oaks, Calif., firm did not disclose the subject of the documents. Amgen said it received a subpoena from the U.S. Attorney's Office for the Eastern District of New York Oct. 25 and a second subpoena from the U.S. Attorney's Office for the Western District of Washington Nov. 1. In addition, on Nov. 2, the Sheet Metal Workers National Health Fund filed suit against Amgen in New Jersey district court alleging federal and state antitrust violations related to anti-competitive bundling and pricing involved in the sale of Neupogen , Neulasta and Aranesp . -Jessica Merrill ([email protected]) |