May 8, 2007 / 1:36 PM / 12 years ago

U.S. FDA staff cautious on anemia drugs' risks

WASHINGTON (Reuters) - U.S. Food and Drug Administration staffers are still cautious over the use of anemia drugs sold by Amgen Inc. and Johnson & Johnson, according to an agency document released on Tuesday.

More data is needed on risks with the injectable drugs, which include Amgen’s Aranesp and Epogen and J&J’s Procrit, the staff said. Changes to the products’ labels to restrict which patients should use them or further limit dosing may also be appropriate, they added.

The agency document was released ahead of an FDA advisory panel meeting on Thursday to discuss the risks of using the medicines in cancer patients amid recent concerns that they are used too aggressively and may harm patients.

In March, FDA officials called for a strong new warning on the medicines and urged doctors to use the lowest dose needed to avoid blood transfusions.

All three drugs are man-made forms of the natural protein erythropoietin and are approved to treat anemia in cancer patients receiving chemotherapy.

They are also cleared for patients with chronic kidney failure and treat anemia by boosting production of hemoglobin — an oxygen-carrying protein in red blood cells.

Shares of the two drug makers fell more than 1 percent in midday trading following the FDA staff’s assessment.

In its review, FDA staff said the uncertainty of the drugs’ risks when used as labeled has not been well addressed in the past three years.

“Additional efforts should be made to obtain such information in a timely manner,” the staff wrote. They added that the medicines’ ability to help patients avoid transfusions “should continue to be weighed against the potential for detrimental effects on survival and tumor growth.”

A number of studies showed an increased risk of thrombovascular problems, which can include heart attacks and strokes, they added.


Separately, Amgen and J&J said they had conducted a comprehensive review and analysis of the available safety data, which they said supports use of anemia drugs as labeled.

“Ongoing pharmacovigilance studies will further inform the risk/benefit assessment in the near future,” they said in another document released on Tuesday.

It is unclear what impact Thursday’s meeting may have on the blockbuster drugs, and analysts have been mixed over whether the FDA’s outside experts will dwell on the drugs’ risks or reaffirm some of their benefits. The agency usually follows the recommendations of its advisers.

Shares of Amgen were off 81 cents at $62.95 on the Nasdaq while shares of J&J were 70 cents lower at $63.56 on the New York Stock Exchange.

The panel’s review could also have implications for Roche Holding AG, which is expecting an FDA approval decision for its rival product Mircera later this month.

Amgen’s drugs Aranesp and Epogen brought in $6.6 billion in 2006, while Procrit saw $3.2 billion in sales.

Deutsche Bank analyst Jennifer Chao said a recent Amgen study of Aranesp in lung cancer patients on chemotherapy may help strike a slightly positive note at the meeting.

That could soften the recent warning “or help to offset additional knee-jerk reactions related to the ‘chicken little’ sentiment responsible for certain recent FDA judgments,” she said in a May 3 research note.

The FDA’s meeting also comes ahead of the U.S. Medicare program’s decision to revisit how it pays for the drugs, and representatives from the federal insurance program are expected to attend.

Medicare, which covers about 43 million elderly and disabled, is considering whether to pay for the medications in non-kidney disease patients and reviewing its coverage policy for kidney disease patients. Both decisions are expected later this year.

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