Drug maker Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs.
The warnings approved by the Food and Drug Administration state that the company’s drugs increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer.
The changes apply to Thousand Oaks, Calif.-based Amgen’s Aranesp and Epogen, as well as Johnson & Johnson’s Procrit. The drugs treat the blood-disorder anemia in patients with kidney failure and those on chemotherapy. Amgen manufacturers all three, though New Brunswick, N.J.-based J & J sells Procrit.
The language states that the problems occurred when doctors treated patients with elevated levels of the drugs, which increase red blood cell levels.
The action came less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.
Since FDA began scrutinizing the drugs last March, shares of Amgen have sunk 27 percent. U.S. sales of its anemia treatments fell more than 10 percent to $6.3 billion for the year.
Wall Street analysts expect sales to fall further in 2008 following next week’s review by FDA’s cancer experts. The panel could recommend halting use of the drugs for certain types of cancers, or in all cancer patients. Recommendations will not apply to Amgen’s Epogen, which is used almost exclusively by kidney failure patients on dialysis.
If FDA removes only some cancer indications, Amgen’s anemia drug sales could lose between $150 million to $250 million for 2008, according to estimates by Goldman Sachs’ analyst May-Kin Ho.
FDA twice updated anemia drug labels last year, most recently in November. Amgen disclosed new data in December on the drugs’ risks in early stage breast cancer and cervical cancer patients, sending shares downward nearly 20 percent. The new label incorporates detail from those studies.
Bear Stearns analyst Mark Schoenebaum said the effect of Friday’s changes would be minimal for Amgen, since cervical cancer accounts for about 1 percent of the Aranesp market. He also noted that the previous label already highlighted the breast cancer risks.
But Stanford Group Co. analyst Gregory Frykman said the new warnings could attract tougher regulations from Medicare, the government’s health plan for seniors. Last summer Medicare ruled that it would only pay doctors to administer anemia drugs if they were prescribed at low levels.
Frykman said the new warnings could convince Medicare to scale back its policy again, perhaps only paying for the drugs when used in certain types of cancer.
Wall Street reacted positively to the news, sending shares up 1.02 cents, or 2.3 percent, to $45.20 in after-hours trading. Shares fell 14 cents to close at $44.18 in regular trading.
Reference Material on Anemia
Anemia, condition in which the concentration of hemoglobin in the circulating blood is below normal. Such a condition is caused by a deficient number of erythrocytes (red blood cells), an abnormally low level of hemoglobin in the individual cells, or both these conditions simultaneously. Regardless of the cause, all types of anemia cause similar signs and symptoms because of the blood’s reduced capacity to carry oxygen. These symptoms include pallor of the skin and mucous membranes, weakness, dizziness, easy fatigability, and drowsiness. Severe cases show difficulty in breathing, heart abnormalities, and digestive complaints.
One of the most common anemias, iron-deficiency anemia, is caused by insufficient iron, an element essential for the formation of hemoglobin in the erythrocytes. In most adults (except pregnant women) the cause is chronic blood loss rather than insufficient iron in the diet, and, therefore, the treatment includes locating the source of abnormal bleeding in addition to the administration of iron.
Pernicious anemia causes an increased production of erythrocytes that are structurally abnormal and have attenuated life spans. This condition rarely occurs before age 35 and is inherited, being more prevalent among persons of Scandinavian, Irish, and English extraction. It is caused by the inability of the body to absorb vitamin B12 (which is essential for the maturation of erythrocytes).
There are several conditions that cause the destruction of erythrocytes, thereby producing anemia. Allergic-type reactions to bacterial toxins and various chemical agents, among them sulfonamides and benzene, can cause hemolysis, which requires emergency treatment. In addition, there are unusual situations in which the body produces antibodies against its own erythrocytes; the mechanism triggering such reactions remains obscure.
A year ago:
FDA issues new warnings on widely used anemia drugs
Federal health officials have issued stern new warnings for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.
Drug maker Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs.
The warnings approved by the Food and Drug Administration state that the company’s drugs increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer.
The changes apply to Thousand Oaks, Calif.-based Amgen’s Aranesp and Epogen, as well as Johnson & Johnson’s Procrit. The drugs treat the blood-disorder anemia in patients with kidney failure and those on chemotherapy. Amgen manufacturers all three, though New Brunswick, N.J.-based J & J sells Procrit.
The language states that the problems occurred when doctors treated patients with elevated levels of the drugs, which increase red blood cell levels.
The action came less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.
Since FDA began scrutinizing the drugs last March, shares of Amgen have sunk 27 percent. U.S. sales of its anemia treatments fell more than 10 percent to $6.3 billion for the year.
Wall Street analysts expect sales to fall further in 2008 following next week’s review by FDA’s cancer experts. The panel could recommend halting use of the drugs for certain types of cancers, or in all cancer patients. Recommendations will not apply to Amgen’s Epogen, which is used almost exclusively by kidney failure patients on dialysis.
If FDA removes only some cancer indications, Amgen’s anemia drug sales could lose between $150 million to $250 million for 2008, according to estimates by Goldman Sachs’ analyst May-Kin Ho.
FDA twice updated anemia drug labels last year, most recently in November. Amgen disclosed new data in December on the drugs’ risks in early stage breast cancer and cervical cancer patients, sending shares downward nearly 20 percent. The new label incorporates detail from those studies.
Bear Stearns analyst Mark Schoenebaum said the effect of Friday’s changes would be minimal for Amgen, since cervical cancer accounts for about 1 percent of the Aranesp market. He also noted that the previous label already highlighted the breast cancer risks.
But Stanford Group Co. analyst Gregory Frykman said the new warnings could attract tougher regulations from Medicare, the government’s health plan for seniors. Last summer Medicare ruled that it would only pay doctors to administer anemia drugs if they were prescribed at low levels.
Frykman said the new warnings could convince Medicare to scale back its policy again, perhaps only paying for the drugs when used in certain types of cancer.
Wall Street reacted positively to the news, sending shares up 1.02 cents, or 2.3 percent, to $45.20 in after-hours trading. Shares fell 14 cents to close at $44.18 in regular trading.
Reference Material on Anemia
Anemia, condition in which the concentration of hemoglobin in the circulating blood is below normal. Such a condition is caused by a deficient number of erythrocytes (red blood cells), an abnormally low level of hemoglobin in the individual cells, or both these conditions simultaneously. Regardless of the cause, all types of anemia cause similar signs and symptoms because of the blood’s reduced capacity to carry oxygen. These symptoms include pallor of the skin and mucous membranes, weakness, dizziness, easy fatigability, and drowsiness. Severe cases show difficulty in breathing, heart abnormalities, and digestive complaints.
One of the most common anemias, iron-deficiency anemia, is caused by insufficient iron, an element essential for the formation of hemoglobin in the erythrocytes. In most adults (except pregnant women) the cause is chronic blood loss rather than insufficient iron in the diet, and, therefore, the treatment includes locating the source of abnormal bleeding in addition to the administration of iron.
Pernicious anemia causes an increased production of erythrocytes that are structurally abnormal and have attenuated life spans. This condition rarely occurs before age 35 and is inherited, being more prevalent among persons of Scandinavian, Irish, and English extraction. It is caused by the inability of the body to absorb vitamin B12 (which is essential for the maturation of erythrocytes).
There are several conditions that cause the destruction of erythrocytes, thereby producing anemia. Allergic-type reactions to bacterial toxins and various chemical agents, among them sulfonamides and benzene, can cause hemolysis, which requires emergency treatment. In addition, there are unusual situations in which the body produces antibodies against its own erythrocytes; the mechanism triggering such reactions remains obscure.
A year ago:
FDA issues new warnings on widely used anemia drugs
Federal health officials have issued stern new warnings for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.
0 comments:
Post a Comment