-- Lopinavir/ritonavir Tablet is the First and Only Co-Formulated
Protease Inhibitor Tablet Approved for Use in Children with HIV
ABBOTT PARK, Illinois, April 7 /PRNewswire/ --
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, Kaletra(R) (lopinavir/ritonavir). The Kaletra
tablet can be taken with or without food and does not require
refrigeration. Lopinavir/ritonavir is marketed as Aluvia(R) in
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
"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
-- 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
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
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
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
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
Web site: http://www.abbott.com