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-Application Seeks Use As Part Of A Combination Regimen In HIV Treatment-Naïve Patients- ABBOTT PARK, Ill., July 26, 2004 -- Abbott Laboratories announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization variation to the European Medicines Agency (EMA), seeking approval of once-daily dosing for its protease inhibitor (PI) Kaletra. The submission package includes data from a clinical study in which once-daily Kaletra had comparable efficacy to twice-daily Kaletra, both dosed in a regimen containing tenofovir and emtricitabine, in treatment-naïve patients. The current adult recommended dosage of Kaletra is 400/100 mg twice daily with food (three pills, twice daily vs. six pills, once daily).
"Patients taking a once-daily Kaletra-based regimen demonstrated a comparable virologic response to the twice-daily regimen," said Joseph Gathe, Jr., M.D., F.A.C.P., lead investigator and clinical instructor at Baylor College of Medicine, and Chief of Infectious Diseases at Park Plaza Hospital in Houston, Texas. "If approved, a once-daily dose would simplify a Kaletra-based treatment regimen while maintaining potency for HIV patients requiring initial therapy for whom alternative dosing options are appropriate."
Among patients who participated in the study submitted, Kaletra was generally well tolerated. In the 48-week study comparing a Kaletra once-daily vs. twice-daily based antiretroviral regimen, the most frequent drug-related adverse events of moderate or greater intensity reported were diarrhea and nausea. Diarrhea was reported more frequently in patients on once-daily therapy (16 percent) versus patients on twice-daily therapy (5 percent).
"As a part of our commitment to the HIV community, Abbott continues to explore additional options in HIV therapy that offer dosing flexibility to patients," said John Leonard, M.D., vice president of Global Pharmaceutical Development, Abbott Laboratories. "We aim to enhance patient choice and convenience without sacrificing efficacy. Kaletra remains an important treatment option in HIV therapy."
Important Safety Information About Kaletra
Kaletra is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Kaletra should not be taken if you have had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir.
Taking Kaletra with certain drugs can cause serious problems or death. Kaletra should not be taken with dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45, Ergotrate Maleate, and Methergine, as well as Halcion®, Hismanal®, Orap, Propulsid, Seldane, Versed®, Rimactane®, Rifadin®, Rifater®, Rifamate®, Mevacor®, Zocor®, or products containing St. John's wort (Hypericum perforatum). Particular caution should be used when taking Viagra®, since the interaction with Kaletra may result in an increase in Viagra-related side effects. Discuss all medicines, including those without a prescription, and herbal preparations you are taking or plan to take with your doctor or pharmacist.
Pancreatitis and liver problems, which can be fatal, have been reported. Tell your doctor if you have had liver disease such as hepatitis. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred. Changes in body fat have been seen in some patients receiving antiretroviral therapy. Some patients receiving Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.
In clinical trials, the most commonly reported side effects of moderate or severe intensity were: abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache and nausea. This is not a complete list of reported side effects. Kaletra oral solution contains alcohol.
Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.
Under accelerated review, the FDA approved Kaletra for marketing on Sept. 15, 2000. Kaletra received full FDA approval on Nov. 27, 2002. Abbott also obtained marketing approval for Kaletra in Canada, Japan, the European Union, throughout Latin America and in additional countries around the world.
According to the updated guidelines released by a panel convened by the U.S. Department of Health and Human Services (DHHS) in March 2004, "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," Kaletra, in combination with zidovudine or stavudine plus lamivudine, are recommended as the preferred PI-based regimens for the treatment of patients new to HIV therapy. Kaletra is the most prescribed protease inhibitor in the United States. For more information, including Kaletra (lopinavir/ritonavir) full prescribing information, please visit www.kaletra.com.
About Abbott
Abbott Laboratories has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood, and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. With Kaletra, Abbott has developed two protease inhibitors, and also offers nutritional products that meet the unique dietary needs of people living with HIV.
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.
Abbott news releases and other information are available on the company's Web site at www.abbott.com.
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