GAITHERSBURG, Md., March 13 /PRNewswire/ -- Ortho Biotech is concerned by the Advisory Committee’s recommendations to restrict access to erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) in patients with metastatic breast and head and neck cancer, and patients treated with curative intent. The company believes that fully informed patients and their physicians should have the choice to use this important medication, which is the only therapeutic alternative to blood transfusion.
“Over the past several months, the company provided the FDA with substantial new data that give important insight into the safety of ESAs,” said Jay Siegel, M.D., Group President, Research & Development. “We hope that the FDA will now take time to review this substantial body of data before reaching its final decision.”
The FDA has not yet reviewed new or follow-up survival data accounting for approximately 50 percent of the 7,444 patients in the company’s database. The totality of available data support continuing the option to use ESAs according to the label in patients with chemotherapy-induced anemia (CIA).
Out of a total of 59 controlled studies with survival data, the FDA has focused on eight studies of concern. All eight studies researched investigational uses of the drug, and the PROCRIT(R) (Epoetin alfa) label contains specific warnings against such uses.
In addition, a representative of the Cochrane Collaboration who attended the meeting confirmed that the group is about to generate important new analyses regarding the safety of ESA use in CIA. The FDA should consider these analyses before making its final decision.
The current product labeling prominently reflects all known risks of ESAs, including thrombovascular events (TVEs). TVEs are a plausible explanation for increased mortality observed in studies with high hemoglobin (Hb) targets. When ESA use is targeted to Hb higher than 12 grams per deciliter of blood (g/dL), the risk is unacceptably increased.
Ortho Biotech will continue to evaluate and minimize risk of ESAs within the labeled treatment setting. We remain committed to continuing to educate healthcare professionals and patients regarding the appropriate use of PROCRIT.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT(R) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
Forward-Looking Statement
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.
CONTACT: Media, Stephanie Fagan, office, +1-908-541-4029, cell,
+1-201-572-9581, sfagan@obius.jnj.com, or Investors, Stan Panasewicz,
+1-732-524-2524, or Tina Pinto, +1-732-524-2034, both for Ortho Biotech
Web site: http://www.procrit.com/
http://www.orthobiotech.com/
http://www.jnj.com/
