Abbott Laboratories

Abbott Laboratories announces the approval of Kaletra(TM) for the treatment of HIV in Europe

    Abbott Park, Illinois (ots-PRNewswire) - Abbott Laboratories (NYSE: ABT) announced today it has received a marketing authorisation from the European Commission for its advanced-generation protease inhibitor (PI), Kaletra(TM) (lopinavir/ritonavir), previously known as ABT-378/r. Kaletra is indicated in combination with other antiretroviral medications for the treatment of HIV infection in adults and children above the age of two years.          "Kaletra has a unique balance of potency, tolerability and durability not found in currently available drug regimens," said William G. Dempsey, senior vice president, international operations at Abbott Laboratories. "It provides a new treatment that is particularly effective for use in patients new to HIV therapy, including children."          The approval of Kaletra was based on extensive clinical data from studies conducted around the world. Phase II and Phase III clinical trials included more than 700 patients from a broad range of patient groups, including those not previously treated with HIV therapy and those who have failed other HIV treatment regimens. Updated results from key Kaletra clinical studies were presented at recent HIV-related scientific meetings, including the Eighth Conference on Retroviruses and Opportunistic Infections, which was held in Chicago in January.          Kaletra's Effectiveness Compared to Nelfinavir          In an ongoing, international Phase III head-to-head clinical trial comparison with nelfinavir, the most widely prescribed protease inhibitor, Kaletra was shown to be more effective at reducing HIV viral levels after nearly one year (48 weeks) of treatment. This is the first reported double- blind clinical study comparing two protease inhibitors. Patients in both treatment arms also received two nucleoside reverse transcriptase inhibitors (NRTIs). After 48 weeks, a significantly higher percentage of patients taking Kaletra (75 percent) achieved undetectable levels of virus (<400 copies/mL) compared to those taking nelfinavir (63 percent), based on an intent-to-treat (ITT) analysis. Using an on-treatment (OT) analysis, 93 percent of patients taking Kaletra compared to 82 percent taking nelfinavir had undetectable viral levels (<400 copies/mL). ITT analyses capture data on all patients entering the study and consider patients with missing data as treatment failures, while OT analyses measure results for patients still participating in the study.          Kaletra's Long-Term Effectiveness as a First-Line PI          An ongoing Phase II study of Kaletra in patients new to therapy showed that after more than 2 years (108 weeks) of therapy, 80 percent of patients taking Kaletra in combination with two NRTIs had undetectable viral levels (<400 copies/mL), using an ITT analysis. For patients remaining on treatment (OT) after more than two years, 99 percent had undetectable levels of virus.          "Patients have the best chance of successfully treating HIV with their first regimen, and study data demonstrate that Kaletra is more effective than nelfinavir when used as a first-line PI," said Eugene Sun, M.D., head of antiviral development at Abbott Laboratories. "In addition, the durable viral suppression seen after more than two years of therapy indicates that Kaletra can effectively provide long-term treatment for people with HIV."          Lack of Resistance Development to Kaletra          An analysis of resistance data from three studies of Kaletra shows that no genotypic resistance has been observed to date in more than 450 patients new to HIV therapy, even after a year or more of treatment in clinical trials. Genotypic testing examines a viral sample for specific mutations, or changes, in the virus that are known to cause resistance to certain drugs. This analysis included data from the study comparing Kaletra with nelfinavir in which viral samples were tested for genotypic resistance in patients with incomplete viral suppression after 24 to 48 weeks of treatment. Results from this analysis showed that none (0/37) of the patients on Kaletra and 33 percent (25/76) of patients on nelfinavir exhibited genotypic resistance.          Viral resistance is one of the main causes of viral rebound and subsequent treatment failure for people with HIV.          Kaletra in Children          In an ongoing Phase II pediatric trial in 100 children (six months to 12 years of age) with Kaletra liquid formulation, Kaletra continues to provide effective, very tolerable treatment. After more than one year (60 weeks) of therapy, 77 percent of children new to HIV therapy and 70 percent of treatment-experienced children achieved undetectable HIV viral levels (<400 copies/mL), using an ITT analysis. Only one child discontinued the study due to Kaletra-related adverse events. All children received Kaletra in combination with NRTIs.          Kaletra in Treatment-Experienced Patients          Two Phase II studies of Kaletra combined with NRTIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs) show durable viral suppression in treatment-experienced patients. In one study of almost two years (96 weeks) in duration, Kaletra combined with the NNRTI nevirapine provided effective and tolerable viral suppression in patients who had previously failed an HIV regimen that included a single PI. In another trial of patients who had previously failed multiple PI regimens, Kaletra combined with the NNRTI efavirenz demonstrated viral suppression after one year (48 weeks) of therapy.          Kaletra is a co-formulation of lopinavir with a small amount of ritonavir. Lopinavir provides the antiviral activity in the formulation, while the ritonavir allows for the achievement of high and sustained lopinavir drug levels in the blood.          "Starting a regimen that achieves high drug levels in the blood allows for sustained viral suppression, thus guarding against the emergence of resistant virus," said Sun. "These high drug levels likely explain the high response rate to Kaletra in clinical trials."          Kaletra should be given with a patient's choice of food twice daily to adults, usually in three capsules or a 5 mL liquid formulation (400/100 mg).          The dose for children two to 12 years old is based on height and weight. Pharmacies should store Kaletra at 2 degrees Celsius-8 degrees Celsius (36 degrees to 46 degrees Fahrenheit). Patients do not need to refrigerate Kaletra if used within six weeks and stored at room temperature up to 25 degrees Celsius (77 degrees Fahrenheit).          The most commonly reported, Kaletra-related adverse events were abdominal pain, abnormal stools, diarrhea, feeling weak or tired, headache, nausea and vomiting.          Based on the urgent need for new treatment options, Abbott initiated its Early Access Program prior to regulatory submission and market authorisation to provide Kaletra to HIV-positive patients who do not have other viable treatment options. The program was designed by working closely with key regulatory agencies and representatives of several HIV treatment organisations, and has been available to more than 15,000 patients in 30 countries worldwide. Abbott will continue to provide Kaletra to patients in countries participating in the program until the drug is available in pharmacies or hospitals to ensure patients will have continued, uninterrupted access to Kaletra.          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 the 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, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 70,000 people and markets its products in more than 130 countries.      ots Original Text Service: Abbott Laboratories Internet:

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