Abbott's Kaletra and Aluvia (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA
Lopinavir/ritonavir tablet is the first and only co-formulated protease inhibitor tablet approved for use in children with HIV
Abbott Park, Illinois, January 28, 2008 - Abbott announced today that the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of a new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir). In addition, the CHMP has adopted a positive opinion, in coordination with the World Health Organization (WHO), for Aluvia (lopinavir/ritonavir), the tradename of the same lower-strength tablet formulation in developing countries.
The new lower-strength formulation is suitable for pediatric use and represents a significant breakthrough for clinicians and patients in developing countries, where more than 2 million of the estimated 2.3 million children worldwide with HIV/AIDS live. The first and only co-formulated protease inhibitor tablet that can be used in children, the tablets do not require refrigeration and can be taken with or without a meal - an important advance in delivering HIV medicine in developing countries.
"EMEA approval is an essential first step to registering the tablet in Europe and most developing countries and it is welcome news for physicians and caregivers of children with HIV," said Mark Kline, M.D., professor of pediatrics, chief of Retrovirology, director, AIDS International Training and Research Program, and director, Baylor-CDC Global AIDS Technical Assistance Project, Baylor College of Medicine. "The development of this product, which does not require refrigeration, is not only a scientific development tailored to the needs of patients, especially children, but also is a huge advance in the care of patients in resource-limited settings." Kline is also president of the Baylor International Pediatric AIDS Initiative at Texas Children's Hospital, which has opened six pediatric centers of excellence throughout Africa and in Romania. Together, these clinics are providing HIV care and treatment to more than 20,000 children.
Next Steps for Making Lower-Strength Pediatric Tablets Broadly Available
The European Commission will review the CHMP's positive opinion for Kaletra and is expected to issue a final decision for marketing authorization for the lower-strength Kaletra in the European Union within the next 60-90 days.
The regulatory review processes in many developing countries require products to receive positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA. The positive opinion is necessary for obtaining a Certificate of Pharmaceutical Product (CPP) - often a prerequisite for regulatory filing in developing countries.
In order to expedite review in developing countries, Abbott is working with regulatory agencies on a country-by-country basis to negotiate submissions before the CPP is available.
The price of the recently approved lower-strength tablet will be half the price of the original-strength tablet everywhere it is available.
Based on the U.S. Food and Drug Administration (FDA) approval on November 9, 2007, Abbott is shipping the lower-strength tablets to countries that have issued approved waiver orders. On December 1, 2007, Uganda, the first country to issue such a waiver order, was one of the first countries in the world - and the first country in Africa - to receive the lower-strength tablets. The Ugandan Government's early approval of the waiver allowed Dr. Victor Musiime of theJoint Clinical Research Centre in Kampala to write the first prescription for the lower-strength tablet just days after the product received marketing authorization in the United States. Other African governments are now also talking to Abbott about the possibility of waiver shipments. According to UNAIDS, an estimated 110,000 Ugandan children were living with HIV in 2005.
The WHO recommends lopinavir/ritonavir as the preferred treatment for children who no longer respond to first-line HIV medicine. The U.S. Department of Health and Human Service recommends lopinavir/ritonavir for the initial treatment of children with HIV.
Kaletra Lower-Strength Tablets
The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its approval in September 2000 in the United States. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility and contains 100mg of lopinavir and 25mg of ritonavir, compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir, most commonly used by adults.
"Abbott has kept the needs of children living in the developing world firmly in mind when making decisions about the development, manufacturing and delivery of our innovative product," said Scott Brun, M.D., divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "We have been addressing the growing epidemic of HIV in children for more than a decade and will continue to for years to come."
Abbott's Commitment to Fighting HIV/AIDS
HIV/AIDS is a global problem that demands shared commitment and shared responsibility. Abbott is committed to working with governments, multilateral organizations, nongovernmental organizations (NGOs) and civil society to expand access to HIV/AIDS treatments around the world.
Abbott has also made significant investments in expanding manufacturing capacity to meet the growing demand for HIV treatment in developing countries.
Abbott's lopinavir/ritonavir formulations are among the lowest-priced protease inhibitors in the developing world. Abbott has been providing its HIV medicines at a price of $500 per adult patient per year in all African and least developed countries (LDCs) since 2002, making these medicines more affordable than any generic copies.
Abbott and Abbott Fund have invested more than in the fight against HIV/AIDS in Africa and the developing world. Abbott Fund-supported programs have served more than 600,000 children and families. In addition, more than 250,000 patients have been tested through Abbott Fund supported voluntary counseling and testing programs, with thousands being referred to treatment programs.
Abbott and Abbott Fund have also announced several efforts to expand access to treatment and care for children living with HIV/AIDS, including an additional investment of in grants and product donations this year.
Abbott Fund is a philanthropic foundation established by Abbott, the global health care company, in 1951. The Fund's mission is to create healthier global communities by investing in creative ideas that promote science, expand health care and strengthen communities worldwide.
Background on HIV in Children
According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2006, an estimated 2.3 million children under the age of 15 were living with HIV/AIDS worldwide; a vast majority - 2 million children with HIV/AIDS - was living in Africa. Last year alone, an estimated 530,000 children were infected with HIV, and 380,000 children died of AIDS.
Based on 2004 Centers for Disease Control and Prevention (CDC) data for 33 states, an estimated 3,336 children under the age of 13 were living with HIV/AIDS in the United States. While the number of pediatric AIDS cases has decreased overall in the U.S., the risk among African-American and Hispanic infants and children is of special concern. Among U.S. children living with AIDS, 63 percent are African-American, are Hispanic, and are Caucasian.
For more information about our commitment to fighting HIV/AIDS, please visit our Web site at www.abbott.com/hiv.
Indication and Important Safety Information for lopinavir/ritonavir
Kaletra is indicated for the treatment of HIV-1 infected adults and children above the age of two years. It is used in combination with other antiretroviral agents.
Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.
Kaletra Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information visit www.KALETRA.com.
Kaletra should not be taken by patients who have had an allergic reaction to any of its ingredients, including lopinavir or ritonavir, or any of the excipients, or by patients with severe liver problems.
Taking certain medications with Kaletra could cause serious side effects that could be life threatening. Do not take Kaletra with astemizole, terfenadine, midazolam, triazolam, pimozide, cisapride, ergotamine, dihydroergotamine, ergonovine, and methylergonovine, rifampicin, amiodarone, vardenafil and products containing St. John's Wort (Hypericum perforatum).
Medical advice and approval must be sought before Kaletra is taken with medicines that lower blood cholesterol (e.g. lovastatinor simvastatin), some medicines affecting the immune system (e.g., cyclosporin, sirolimus (rapamycin), tacrolimus), various steroids (e.g., dexamethasone, fluticasone propionate, ethinyl oestradiol), other protease inhibitors, certain heart medicines such as calcium channel antagonists, (e.g., felodipine, nifedipine, nicardipine) and medicines used to correct heart rhythm (e.g., bepridil, systemic lidocaine, quinidine), antifungals, (e.g., ketoconazole, itraconazole), morphine-like medicines (e.g., methadone) anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital), warfarin, certain antibiotics (i.e., rifabutin, clarithromycin), certain antidepressants (e.g. trazodone) and voriconazole.
Kaletra may interact with erectile dysfunction agents (e.g., sildenafil or tadalafil). Lower doses of these medicines should be prescribed in patients taking Kaletra.
Kaletra may interact with digoxin (heart medicine); monitoring by a physician is recommended.
Taking Kaletra with certain medicines can cause increased levels of these other medicines in the body. This could increase or prolong their effects and/or adverse reactions, which may result in serious or life-threatening problems. Because of this, patients must tell their doctor about all medicines they are taking or planning to take, including those medicines that can be bought without a prescription and herbal preparations.
Patients using an oral contraceptive or using a patch contraceptive to prevent pregnancy should use an additional or alternative type of contraception since Kaletra may reduce the effectiveness of these products.
Pregnant or nursing mothers should not take Kaletra unless specifically directed by their doctor.
Kaletra oral solution contains alcohol. While taking Kaletra oral solution, patients should not take any medicines that may cause a reaction with alcohol such as disulfiram.
It is important that Kaletra oral solution is taken with food. Kaletra tablets may be taken with or without food.
Cases of pancreatitis have been reported in patients taking Kaletra. Liver problems, which can be fatal, have also been reported. Patients should tell their doctor if they have had liver disease such as chronic or C as they are at increased risk for severe and potentially fatal liver adverse events. These patients may require blood tests for control of liver function.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Patients should contact their doctor if they notice changes in body fat.
In patients taking protease inhibitors, increased bleeding (in patients with hemophilia type A and B) has been reported.
Combination antiretroviral therapy may cause new cases of diabetes and high blood sugar or worsening of existing diabetes, as well as increased fats and raised lactic acid in the blood. The long-term risks for complications due to increases in triglycerides and cholesterol are not known at this time. In addition, large amounts of triglycerides have been considered a risk factor for pancreatitis.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. Symptoms of infection should be reported to a doctor immediately.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis. Signs and symptoms are joint stiffness, aches and pains (especially in the hip, knee and shoulder) and difficulty in movement. These symptoms require that patients contact their doctor.
In lopinavir/ritonavir lopinavir/ritonavir adult clinical trials, the very commonly reported out of 10 persons treated) and commonly reported (less than 1 out of 10 but more than 1 out of 100 persons treated) side effects of moderate to severe intensity were diarrhea, insomnia, headache, nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder, rash, lipodystrophy, weakness, and abnormal liver enzymes. This is not a complete list of reported side effects.
In children two years of age and older, the safety profile is similar to that seen in adults.
For more information about Kaletra, please consult your local prescribing information.
Kaletra tablets do not require any special storage conditions.
Kaletra oral solution: Store in a refrigerator (2°-8° C). If kept outside of the refrigerator, do not store above 25° C and discard any unused contents after 42 days (6 weeks). Avoid exposure to excessive heat.
Abbott and HIV/AIDS
Abbott 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. Abbott has developed two protease inhibitors for the treatment of HIV.
Abbott 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 65,000 people and markets its products in more than 130 countries.
For more information on Abbott's HIV/AIDS programs, please visit www.abbott.com/HIVAIDS and www.abbottglobalcare.org.
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