主页 > 医学信息 >

【drug-news】FDA: 安进EPO用于化疗后贫血可以, 但要

FDA Panel Wants Limits on Anemia Drugs
Thursday March 13, 8:51 pm ET
By Matthew Perrone, AP Business Writer
FDA Panel Favors Amgen, J&J Anemia Drugs for Chemotherapy, but With Restrictions

WASHINGTON (AP) -- Federal advisers said anemia drugs sold by Amgen Inc. and Johnson & Johnson should be sharply restricted to a segment of cancer patients -- a recommendation that could cost the companies millions.

The limits, proposed Thursday by a Food and Drug Administration panel, were the latest blow to three blockbuster medications already plagued by concerns over increased risks of death and tumor growth.

The cancer experts overwhelmingly voted to keep the drugs on the market for chemotherapy patients, but said use should be limited to those with uncurable forms of cancer. The experts also voted nine-to-five to withdraw the drug's use in patients with breast or head-and-neck cancers, such as those affecting the sinuses, throat and lymph nodes.

FDA often follows its panelists' advice, though it is not required to do so. Agency staffers said they would begin considering the recommendations immediately, but set no timetable for action.

FDA's director for new drugs said the votes reflect the unresolved safety questions.

"It was clear from the discussion that they are concerned about the risks of these drugs, but the scope of those risks is not clear," John Jenkins said. "We don't have perfect data at this point."

The recommendation was not as restrictive as some on Wall Street had feared, and shares of Amgen climbed by nearly 5 percent in afternoon trading. Many analysts said the panel could have recommended halting the drugs' use in all chemotherapy patients, endangering as much as $1 billion in Amgen sales.

FDA already bolstered warning labels on the treatments -- Aranesp, Epogen and Procrit -- three times in the past year. But the action recommended Thursday would go much further, effectively wiping out a large slice of the market for anemia drugs. Amgen manufactures all three; New Brunswick, N.J.-based J&J sells Procrit.

Bear Stearns analyst Mark Schoenbaum estimated the restrictions could eliminate about 40 percent of the market for Amgen's best-seller Aranesp. Epogen is better insulated because it's used almost exclusively by kidney dialysis patients.

The two combined accounted for $6.2 billion, or more than 40 percent, of the Thousand Oaks, Calif.-based company's revenue last year. Procrit had sales of $2.9 billion, or less than 5 percent of J&J's total sales.

Earlier on Thursday, FDA staff told panelists there is no definitive evidence that the blockbuster anemia drugs are safe when used as recommended.

Amgen and J&J representatives argued Thursday that the problems cited by FDA have been inconsistently reported across dozens of studies. And they pointed out that only studies involving higher-than-recommended dosing levels showed significant safety risks.

The companies outlined a large-scale study Thursday to try and answer whether anemia drugs hasten death and tumor growth when used according to the current label, but results won't be available for at least five years.

Until then, the companies proposed educational outreach to doctors.

The debate over whether the drugs are overused remains -- and riled some panelists who questioned Amgen's promotional tactics. Giving discounts to doctors who order large quantities of the drug encourages overuse, many cancer experts argue.

During the meeting, panelist Michael Perry pressed an Amgen executive to explain the rebates and discounts. The response from Vice President Joshua Ofman was long and complicated.

"You ought to be on 'Dancing with the Stars,'" said Perry, director of the Ellis Fischel Cancer Center. "You can't dance your way out of a yes or no question."

Ofman then confirmed that Amgen does offer rebates and discounts for doctors who purchase large amounts.

Shares of Amgen rose $2.19, or 4.9 percent, to close at $47.18. J&J's stock rose 26 cents to $62.81. FDA Panel Wants Limits on Anemia Drugs
FDA专家小组限制抗贫血药物的使用


Thursday March 13, 8:51 pm ET
3月13日,星期四,美国东部时间8:51

By Matthew Perrone, AP Business Writer
美联社商务记者Matthew Perrone

FDA Panel Favors Amgen, J&J Anemia Drugs for Chemotherapy, but With Restrictions
FDA专家小组允许安进、强生的药物用于化疗患者,但要严格限制

WASHINGTON (AP) -- Federal advisers said anemia drugs sold by Amgen Inc. and Johnson & Johnson should be sharply restricted to a segment of cancer patients -- a recommendation that could cost the companies millions.
华盛顿(美联社)----美国政府专家声称应当严格限制安进(Amgen)、强生(Johnson & Johnson)公司制造的抗贫血药,仅用于部分肿瘤患者----一个价值数百万的建议。

The limits, proposed Thursday by a Food and Drug Administration panel, were the latest blow to three blockbuster medications already plagued by concerns over increased risks of death and tumor growth.

阅读本文的人还阅读:

【medical-news】小鼠试验可

【Endocrinology】抑制NF-k

【medical-news】《Nature》:

【medical-news】通过饮食增

作者:admin@医学,生命科学    2011-01-18 17:14
医学,生命科学网