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New Anemia-Drug Restrictions Possible!!!!!!


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New Anemia-Drug Restrictions Possible

J&J, Amgen Brace

For FDA Advisory

On Approved Uses


March 12, 2008; Page D7

The Food and Drug Administration is considering tough new restrictions for the blockbuster anemia drugs sold by Johnson & Johnson and Amgen Inc., including possibly revoking the agency's approval for their use in cancer patients.

Tomorrow, the FDA's cancer-drugs advisory committee will recommend what action the regulator should take based on growing evidence of potential safety concerns for cancer patients taking the drugs, sold as Procrit by J&J and Epogen and Aranesp by Amgen. Studies have tied the drugs to shortened survival times and faster tumor growth, as well as a risk of blood clots, under certain circumstances.

The agency will ask its advisers to weigh several possible curbs that would go well beyond current safety warnings in the drugs' labels, including eliminating their approval for use in cancer patients, according to documents made public yesterday.

The labels currently focus cancer-patient warnings largely on use of the drugs at doses higher than recommended. In the newly unveiled documents, the FDA doesn't limit its concerns to the high doses. Instead, it says "there is insufficient safety data" to rule out serious risks to patients with any cancer except small-cell lung disease. The FDA says, "there is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a re-assessment of the net benefits of this class of drugs." Thrombotic effects are related to blood clots.

Among the potential new restrictions: requiring cancer patients to sign informed consents before they take the medicines, confining distribution of the drugs, or asking the drugs' makers to voluntarily limit their advertising and promotion. The drugs are used to boost red-blood-cell production in cancer patients whose anemia stems from chemotherapy, reducing the need for blood transfusions.

Such restrictions, particularly removal of FDA approval for use in cancer patients, would be serious blows to the companies. The drugs would remain on the market for other uses, particularly in kidney failure. Doctors are allowed to prescribe drugs for uses that the FDA doesn't endorse, but sometimes insurers won't pay for such "off-label" prescriptions. Also, if the approved use is removed for safety reasons, doctors may be reluctant to continue such prescribing because of liability concerns.

Procrit had world-wide revenue of $2.8 billion last year; J&J said it couldn't break out cancer-related sales. Aranesp had sales of $3.61 billion in 2007, and Amgen said $1.55 billion was for U.S. cancer patients, while $550 million was for foreign oncology prescriptions.

Amgen's U.S. patents on Aranesp expire in 2024, and European patents expire in 2010 to 2014. Amgen's Epogen patents, all U.S., expire in 2012 to 2015.

Epogen is marketed only for kidney-failure patients on dialysis, because Amgen licensed other uses of the drug to J&J, which sells it under the Procrit name. Roche Holding AG makes a similar drug called Mircera, and the company is locked in a court battle with Amgen over whether it will be able to market it in the U.S.

J&J and Amgen defended the drugs in statements. J&J said they are "safe and effective when used according to the product label to treat chemotherapy-induced anemia." Amgen said they "provide an important clinical option for some patients" and offer "an unequivocal treatment benefit for cancer patients undergoing chemotherapy by reducing the need for blood transfusions which have both known and unknown risks." Amgen said the safety issues have been tied to uses, or dosing regimens, of the drugs that aren't currently recommended.

Sales of the medications have dropped since last March, when they got tough, "black-box" safety warnings on their labels related to cancer patients and other uses. The concerns have particularly eroded the stock price of Amgen, whose market capitalization has plunged by more than $28 billion. In NASDAQ trading yesterday, Amgen shares closed at $44.62, down six cents. J&J shares closed at $62.44, up $1.11, or 1.8%.

The drugs' label warnings were updated last week. The FDA's cancer-drugs panel examined the safety issues last May. Perhaps most significantly, the Centers for Medicare and Medicaid Services last summer unveiled a new reimbursement policy that limited the dosing of the drugs for cancer patients.

In addition to the possibility of eliminating the drugs' approved use in cancer patients, the FDA asks its advisers whether it should consider more targeted limits, such as recommending the drugs' use only in small-cell-lung-cancer patients.

As data mounted over the past year, Amgen abandoned its position that favored the testing of aggressive anemia treatments to fight tumors. Its fallback position merely tries to hold the line at FDA's more-conservative label limits while preserving some role for the drugs in chemotherapy-induced anemia.

Among dwindling supporters for Amgen's position is the American Society of Hematology, which "does not see sufficient evidence of harm to support recommending the complete cessation of the use...across all patients with malignancies," says University of Michigan Professor of Medicine Sam Silver.

Write to Anna Wilde Mathews at anna.mathews@wsj.com and Marilyn Chase at marilyn.chase@wsj.com

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The FDA advisory committee voted 13-1 on March 13, 2008 to recommend that anemia drugs sold by Amgen and Johnson & Johnson still be available for cancer patients.

But the panel also said the drugs shouldn’t be given to patients who are receiving potentially curative treatments — a recommendation whose effects could be “quite significant,” analyst Eric Schmidt of Cowen and Co. told the WSJ.

For about a year now, regulators have been looking into suggestions that the drugs, sold under the brand names Aranesp, Epogen and Procrit, might increase the risk of death and fuel the growth of tumors. But much of that evidence comes from studies in which patients were treated more aggressively than the drugs’ labels recommend.

The FDA has said there is now mounting evidence of documented effects on survival, tumor progression and thrombotic events which require a reassessment of the net benefit of this class of drugs.

The drugs, known as ESAs, have combined sales of over $6 billion a year. The panel also endorsed a proposal that Amgen has backed that would require an unusually stringent informed consent procedure for cancer patients who receive the drug.

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I believe this anemia drug situation applies the same with Avastin in the adjuvant setting. It is hard to tell a medical oncologist (and patient) to ratchet back on the drug they're using when the disease setting is stage IV. Therapy-related, late onset sequelae are becoming a very real problem. Few drugs work the way oncologists think and few take the time to think through what it is they are using them for.

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