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Abbott's Kaletra(R) And Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet For Pediatric Use Receives Positive Opinion From EMEA
Abbott (NYSE: ABT) 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(R) (lopinavir/ritonavir). In addition, the CHMP has
adopted a positive opinion, in coordination with the World Health
Organization (WHO), for Aluvia(R) (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 the Joint 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 $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 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.
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, 21.6 percent are Hispanic, and 14.2
percent are Caucasian.
For more information about our commitment to fighting HIV/AIDS, please
visit our Web site at http://www.abbott.com/hiv.
About Kaletra
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 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 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.
Storage Conditions
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
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. For more information on
Abbott's HIV/AIDS programs, please visit http://www.abbott.com/HIVAIDS and
http://www.abbottglobalcare.org.
Abbott
http://www.abbott.com
View drug information on Kaletra Capsules and Oral Solution; Warfarin Sodium tablets.
Abbott de Kaletra (R) ºi Aluvia (R) (lopinavir / ritonavir) Nou de Jos-Tablet Forþa de aderenþã pentru utilizare in pediatrie a primit aviz pozitiv din EMEA - Abbott's Kaletra(R) And Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet For Pediatric Use Receives Positive Opinion From EMEA - articole medicale engleza - startsanatate