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Abbott's New Aluvia (lopinavir/ritonavir) Tablet Approved in Nineteen African Countries
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- First Approvals in Africa for New Non-Refrigerated Formulation of a Leading Protease Inhibitor -
Abbott press release
JOHANNESBURG, SOUTH AFRICA, July 25, 2007 - Abbott announced today that it has received approval from nineteen African countries for Aluvia, the new tablet formulation of its protease inhibitor lopinavir/ritonavir, for the treatment of HIV. Currently, the new lopinavir/ritonavir tablet is approved in the following African countries: Angola, Benin, Botswana, Burundi, Comoros, Djibouti, Democratic Republic of Congo, Ghana, Kenya, Libya, Malawi, Mauritius, Namibia, Rwanda, Senegal, Sierra Leone, Tanzania, Uganda, and Zambia. Aluvia tablets now have been either filed or approved in African countries that account for more than 95 percent of HIV burden.
In addition to these 19 approvals, Abbott has worked diligently to register the tablet around the world with total filings in 137 countries and approvals in 90. Ultimately, this new tablet formulation will be available in more than 150 countries as Abbott maintains Aluvia as the most widely available protease inhibitor of its type in the world. Abbott continues to make progress toward making Aluvia as broadly available as possible in areas of high HIV prevalence, such as South Africa. The original lopinavir/ritonavir capsule is registered in 118 countries, making it the most widely registered HIV medicine (according to World Health Organization data).
"The arrival of a protease inhibitor that doesn't require refrigeration is very good news for HIV patients in Zambia," commented Kwasi Torpey, M.D., M.P.H., director, Technical Support, Family Health International, a non-profit organization that provides research, education, and treatment services to HIV/AIDS patients in more than 70 countries. "Temperatures here may be over 30 degrees Celsius in some areas and cooling equipment is not easily accessible. We look forward to working with Abbott to ensure that patients get these new Aluvia tablets as quickly as possible."
In the effort to make the new heat-stable tablet formulation of lopinavir/ritonavir available in developing world countries, Abbott is placing an emphasis on accelerated filings. Abbott is working with global regulatory agencies on a country-by-country basis to negotiate early regulatory submissions with local governments and will continue to explore all locally acceptable regulatory opportunities that will speed access to patients as soon as possible. In fact, in recent months more than half of all shipments into Africa have been the new heat-stable Aluvia tablet. In some areas, local governments have approved the importation of heat-stable Aluvia via waivers.
Lopinavir/ritonavir has been available in soft-gel capsules (known as Kaletra) and as an oral solution since first approved in the United States in September 2000. Using its new proprietary Meltrexþ technology, Abbott has developed and received approval for a tablet formulation (marketed as Kaletra or as Aluvia in the developing world) that offers increased dosing convenience (a total daily dose of four tablets, instead of six soft-gel capsules) and allows dosing with or without food for adult patients. It maintains a similar safety and efficacy profile as the soft-gel capsule. Most importantly, the new tablet does not require refrigeration. The new lower-strength tablet, suitable for pediatric use, will have these same convenience benefits as the standard Kaletra or Aluvia 200/50 mg tablets.
Abbott will maintain its current lopinavir/ritonavir price of $500 per patient, per year in Africa and the Least Developed Countries (LDCs) for the new formulation. By maintaining this price, lopinavir/ritonavir will continue to be one of the lowest-priced protease inhibitors (branded and generic) in Africa and the LDCs.
"Bringing a heat-stable tablet version of lopinavir/ritonavir to Africa has been a top priority, and a key step in our commitment to improve patient care for the global HIV/AIDS community," said Mark Masterson, vice president, Pacific/Asia/Africa, Abbott. "The approval of the tablet in these nineteen African countries is just the beginning, and we hope that very soon patients throughout Africa will have access to this vital medicine, with its demonstrated safety and efficacy profile."
In addition to the continued filings and approvals of the standard Aluvia 200/50 mg tablets in Africa, Abbott announced last week that it has applied to the European Medicines Agency (EMEA) and to the U.S. Food and Drug Administration (FDA) for approval of a new lower-strength lopinavir/ritonavir tablet. Abbott's lopinavir/ritonavir 100/25 mg tablet is the first and only co-formulated protease inhibitor tablet developed to increase dosing options in the pediatric setting.
Status of Lopinavir/Ritonavir 200/50 mg Tablet Registrations
Although these countries represent the first approvals of the Aluvia tablet in Africa, Abbott has been working closely with the governments of other African countries to expedite the filing and review process since early 2006.
In addition to the current approvals and filings in Africa, Abbott is also working to register the lopinavir/ritonavir tablet in Asia, Europe and Latin America as rapidly as possible. Within Asia, Abbott has already registered and marketed the tablet in countries, such as Hong Kong, Japan, Australia and New Zealand. The tablet has also been registered in nearly all of Latin America, including Brazil, Peru, Colombia, Argentina, Ecuador, Guatemala, Dominican Republic, Chile, Mexico, Uruguay, Paraguay and Venezuela.
Abbott Invests in Meeting the Needs of HIV Patients in Developing Countries
Abbott has made significant investment in advanced technologies to bring this new formulation to HIV patients, including expanding manufacturing capacity to meet the growing demand for second-line HIV treatment in developing countries.
Indication and Important Safety Information for Lopinavir/ritonavir
Indication
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 lovastatin, 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 (i.e., 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 common and commonly reported 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.
Storage Conditions:
Kaletra tablets do not require any special storage conditions.
Kaletra oral solution: Store in a refrigerator (2o-8o C). If kept outside of the refrigerator, do not store above 25o C and discard any unused contents after 42 days (6 weeks). Avoid exposure to excessive heat.
About Abbott and Abbott Fund
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 and Abbott Fund have invested more than $100 million 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 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.
About Abbott
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.
Abbott's news releases and other information are available on the company's
Web site at www.abbott.com. For more information on Abbott Fund's HIV/AIDS programs, please visit www.abbottglobalcare.org.
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