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Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
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Abbott Will Register and Make the New Lower-Strength lopinavir/ritonavir Tablet Available in More Than 150 Countries to Support Broad Access for the More Than 2 Million Children Living with HIV Worldwide
ABBOTT PARK, Ill., Nov. 12 /PRNewswire-FirstCall/ -- Abbott today
announced that it has received U.S. Food and Drug Administration (FDA) approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir), which is also marketed as Aluvia (lopinavir/ritonavir) in developing countries. The lower-strength Kaletra tablets will be available in the U.S. this month.
Abbott is awaiting EMEA marketing authorization for the Kaletra/Aluvia lower-strength tablets. Upon EMEA marketing authorization, Abbott intends to register this new tablet formulation in more than 150 countries. The soft gel capsule formulation of LPV/r is the most widely registered protease inhibitor in the world. The original tablet formulation is already available in 93 countries and Abbott is awaiting approval in an additional 45 countries for this formulation.
Approval of this lower-strength Kaletra tablet represents an important step in Abbott's ongoing commitment to the global fight against HIV because:
-- The tablets do not require refrigeration and can be taken with or
without a meal -- an important advance in delivering HIV medicine to children in developing countries.
-- The World Health Organization (WHO) estimates 2 million children were living with HIV/AIDS in sub-Saharan Africa at the end of 2006.
-- The new lower-strength tablets are smaller in size than original
Kaletra tablets and contain the same proven active ingredients as
Abbott's Kaletra oral solution. The lower-strength Kaletra tablet is
approved for children weighing 15kg or more who are able to swallow the intact tablet.
-- The FDA approval expands available options for using the first and only co-formulated protease inhibitor tablet to treat children with HIV.
"HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world," said Scott Brun, M.D., divisional vice president, infectious diseases and renal development, Global Pharmaceutical Research and Development, Abbott. "Abbott developed a lower-strength tablet formulation of Kaletra to give physicians an innovative treatment option to help curb the impact of HIV infection in children."
The price of the recently approved lower-strength tablet will be half the price of the original tablet in the developing world.
About 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.
About 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 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 the Abbott Fund are investing more than $100 million in developing countries through the Abbott Global AIDS Care programs focusing on four areas: strengthening health care systems; helping children affected by HIV/AIDS; preventing mother-to-child transmission of HIV; and expanding access to testing and treatment. 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 $12 million in grants and product donations this year.
Background on HIV in Children
According to the WHO, an estimated 2.3 million children under the age of 15 worldwide were living with HIV/AIDS in 2006; a vast majority - 2 million children with HIV/AIDS -- was living in Africa. 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, 21.6 percent are Hispanic, and 14.2 percent are Caucasian. The U.S. Department of Health & Human Services (HHS) and the WHO recommend lopinavir/ritonavir for the treatment of children with HIV.
Indication
KALETRA(R) (lopinavir/ritonavir) is a human immunodeficiency virus-1 (HIV-1) protease inhibitor. KALETRA is always used in combination with other anti-HIV-1 medicines for the treatment of HIV-1 infection. KALETRA is a combination of two medicines, lopinavir and ritonavir. KALETRA is for adults and for children age 6 months and older.
Important Safety Information
KALETRA does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others.
KALETRA must not be taken by patients who have had an allergic reaction to KALETRA or any of its ingredients.
Taking KALETRA with certain drugs can cause serious problems or death. KALETRA must not be taken with dihydro-ergotamine, ergonovine, ergotamine, or methylergonovines such as Cafergot(R), Migranal(R), D.H.E. 45(R), ergotrate maleate, and methergine, as well as Halcion(R) (triazolam), Orap(R) (pimozide), Propulsid(R) (cisapride), or Versed(R) (midazolam).
KALETRA must not be taken with rifampin, also known as Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R); St. John's wort (Hypericum perforatum); Mevacor(R) (lovastatin), or Zocor(R) (simvastatin).
There are drug-drug interactions with the potential for risk of serious or life-threatening side effects. Alterations in dose, increased monitoring of drug levels in the blood, or increased observations for side effects may be recommended when KALETRA is taken with: Lipitor(R) (atorvastatin), Crestor(R) (rosuvastatin), Viagra(R) (sildenafil), Cialis(R) (tadalafil), Levitra(R) (vardenafil), oral contraceptives ("the pill") or the contraceptive patch, Mycobutin(R) (rifabutin), inhaled Flonase(R) (fluticasone), metronidazole, or disulfiram. Patients should talk with their doctor about all medicines they are taking or planning to take, including those without a prescription and herbal products.
KALETRA should not be given once-daily in combination with Sustiva(R) (efavirenz), Viramune(R) (nevirapine), Agenerase(R) (amprenavir), fosamprenavir, Viracept(R) (nelfinavir), phenobarbital, phenytoin (Dilantin(R)) or carbamazepine (Tegretol(R)).
Patients and/or their care providers should pay special attention to accurate administration of the KALETRA dose to reduce the risk of accidentally giving too much or too little medicine.
The most commonly reported side effects of moderate severity that are thought to be drug related are abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea. Children taking KALETRA may sometimes get a skin rash. Other side effects may occur.
Pancreatitis and liver problems, which can be fatal, have been reported in patients receiving KALETRA. Patients should tell their doctor if they have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if they have or have had liver disease such as Hepatitis B or C.
Some patients have had large increases in triglycerides and cholesterol. Changes in body fat have been seen in some patients taking anti-HIV therapy. The long-term health effects of these conditions are not known at this time. Diabetes and high blood sugar have occurred in patients taking protease inhibitors such as KALETRA.
Some patients with hemophilia have increased bleeding with protease inhibitors.
The effects of KALETRA on pregnant women or their unborn babies are not known. Mothers taking KALETRA should not breast-feed.
All strengths of KALETRA tablets should be swallowed whole and not chewed, broken, or crushed.
KALETRA tablets should be stored at room temperature. Exposure of this product to high humidity outside the pharmacy container for longer than 2 weeks is not recommended.
Refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 77 F (25 C), KALETRA oral solution should be used within 2 months.
Avoid exposure to excessive heat. For full prescribing information
visit http://www.kaletra.com.
Abbott and HIV
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.
Expanding on its scientific contributions, Abbott and Abbott Fund have invested more than $100 million in developing countries to improve the lives of people affected by HIV/AIDS through programs targeting critical areas of need, including strengthening health care systems and supporting children affected by HIV/AIDS and advancing HIV testing and treatment. For more information on Abbott's HIV/AIDS programs, please visit
http://www.abbott.com/HIVAIDS and http://www.abbottglobalcare.org.
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 http://www.abbott.com
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