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News Release - April 7, 2008
New Abbott Kaletra(R) (lopinavir/ritonavir) Lower-Strength Tablet for Pediatric Use Approved in EuropeLopinavir/ritonavir Tablet is the First and Only Co-Formulated Protease
Inhibitor Tablet Approved for Use in Children with HIV
ABBOTT PARK, Illinois, April 7 (HSMN NewsFeed) -- Abbott announced today that it has received marketing authorization from the European Commission for the new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, KaletraŽ (lopinavir/ritonavir). The Kaletra tablet can be taken with or without food and does not require refrigeration. Lopinavir/ritonavir is marketed as AluviaŽ in developing countries.
European approval is a critical step in Abbott's efforts to expedite registration filings for the lower-strength tablet formulation in countries around the world, including in developing countries where more than 2 million of the estimated 2.3 million children worldwide with HIV/AIDS live. In Europe, there are approximately 4,000 children living with HIV.
Currently, the lower-strength tablet is available or approved in 53 countries in Europe, Africa, Asia, Latin America and in North America, and is filed in an additional 11 countries. European Commission approval is significant for many developing countries because they require documentation of the marketing authorization to obtain 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. Abbott intends to make the lower-strength tablet available or approved in 155 countries around the world, just as it has done with the adult tablet.
"The lower-strength Kaletra formulation is the first and only co-formulated protease inhibitor tablet that can be used in children of appropriate age, weight or body surface area, representing a significant breakthrough for clinicians treating children with HIV in both developed and developing countries," said Carlo Giaquinto, M.D., Department of Pediatrics, University of Padua, Italy, chair of PENTA (Pediatric European Network for Treatment of AIDS).
The lower-strength Kaletra tablet offers HIV-positive children new benefits not available with the current soft capsules or oral solution, enhancing the dosing convenience without compromising efficacy.
-- Simple tablet form -- the lower-strength tablet is more convenient to administer than the oral solution.
-- Dosing is with or without food, providing patients greater flexibility -- the current soft capsule formulation should be taken with food.
-- No required refrigeration -- unlike the current soft capsule formulation or oral solution, which require refrigeration, the new Kaletra tablet can be stored at room temperature.
"HIV/AIDS continues to have a devastating effect on millions of children around the world, especially those patients living in resource-limited settings," said Scott Brun, M.D., divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "The new lower-strength Kaletra formulation is another example of Abbott's continued commitment to advancing treatment and care for the HIV community."
Kaletra Lower-Strength Tablet Availability
Based on the U.S. Food and Drug Administration (FDA) approval on Nov. 9, 2007, Abbott is shipping the lower-strength tablets to countries that have issued approved waiver orders. On Dec. 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. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), an estimated 110,000 Ugandan children were living with HIV in 2005. Other African governments are now also talking to Abbott about the possibility of waiver shipments.
The World Health Organization 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 U.S. approval in September 2000. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility. The tablets contain 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.
The price of the lower-strength tablet will be half the price of the original-strength tablet everywhere it is available.
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 patient groups to expand access to HIV 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 US$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 the company's philanthropic foundation Abbott Fund have invested more than US$100 million in the fight against HIV/AIDS in Africa and the developing world. Abbott Fund-supported programs have served more than 700,000 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 also has donated more than 8 million rapid HIV tests to help prevent mother-to-child HIV transmission.
Abbott and Abbott Fund also have announced several efforts to expand access to treatment and care for children living with HIV/AIDS, including an additional investment of US$12 million in grants and product donations this year.
Background on HIV in Children
According to UNAIDS, in 2007, an estimated 2.5 million children under the age of 15 were living with HIV worldwide; a vast majority -- almost 90 percent of children with HIV -- were living in sub-Saharan Africa. Last year alone, an estimated 420,000 children under age 15 were newly infected with HIV, and 330,000 children under age 15 died of AIDS.
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 http://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 42 percent 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 hepatitis B 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 adult clinical trials, the very commonly reported (>1 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 degrees - 8 degrees C). If kept outside of the refrigerator, do not store above 25 degrees 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.
About Abbott and Abbott Fund
Abbott (NYSE: ABT ) 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 68,000 people and markets its products in more than 130 countries.
Abbott Fund is a philanthropic foundation established by Abbott in 1951. Abbott Fund's mission is to create healthier global communities by investing in creative ideas that promote science, expand health care and strengthen communities worldwide.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com. For more information on Abbott's HIV/AIDS programs, please visit http://www.abbott.com/HIVAIDS and http://www.abbottglobalcare.org.
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