Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA
Abbott Park, Illinois (ots/PRNewswire) -
- Lopinavir/ritonavir tablet is the first and only co-formulatedprotease inhibitor tablet approved for use in children with HIV
Abbott (NYSE: ABT) announced today that the European Committee forMedicinal Products for Human Use (CHMP), the scientific committee ofthe European Medicines Agency (EMEA), has issued a positive opinionrecommending approval of a new, lower-strength tablet formulation ofthe company's leading HIV protease inhibitor, Kaletra(R)(lopinavir/ritonavir). In addition, the CHMP has adopted a positiveopinion, in coordination with the World Health Organization (WHO),for Aluvia(R) (lopinavir/ritonavir), the tradename of the samelower-strength tablet formulation in developing countries.
The new lower-strength formulation is suitable for pediatric useand represents a significant breakthrough for clinicians and patientsin developing countries, where more than 2 million of the estimated2.3 million children worldwide with HIV/AIDS live. The first and onlyco-formulated protease inhibitor tablet that can be used in children,the tablets do not require refrigeration and can be taken with orwithout a meal -- an important advance in delivering HIV medicine indeveloping countries.
"EMEA approval is an essential first step to registering thetablet in Europe and most developing countries and it is welcome newsfor physicians and caregivers of children with HIV," said Mark Kline,M.D., professor of pediatrics, chief of Retrovirology, director, AIDSInternational Training and Research Program, and director, Baylor-CDCGlobal AIDS Technical Assistance Project, Baylor College of Medicine."The development of this product, which does not requirerefrigeration, is not only a scientific development tailored to theneeds of patients, especially children, but also is a huge advance inthe care of patients in resource-limited settings." Kline is alsopresident of the Baylor International Pediatric AIDS Initiative atTexas Children's Hospital, which has opened six pediatric centers ofexcellence throughout Africa and in Romania. Together, these clinicsare providing HIV care and treatment to more than 20,000 children.
Next Steps for Making Lower-Strength Pediatric Tablets BroadlyAvailable
The European Commission will review the CHMP's positive opinionfor Kaletra and is expected to issue a final decision for marketingauthorization for the lower-strength Kaletra in the European Unionwithin the next 60-90 days.
The regulatory review processes in many developing countriesrequire products to receive positive opinion from the Committee forMedicinal Products for Human Use (CHMP), the scientific committee ofthe EMEA. The positive opinion is necessary for obtaining aCertificate of Pharmaceutical Product (CPP) -- often a prerequisitefor regulatory filing in developing countries.
In order to expedite review in developing countries, Abbott isworking with regulatory agencies on a country-by-country basis tonegotiate submissions before the CPP is available.
The price of the recently approved lower-strength tablet will behalf the price of the original-strength tablet everywhere it isavailable.
Based on the U.S. Food and Drug Administration (FDA) approval onNovember 9, 2007, Abbott is shipping the lower-strength tablets tocountries that have issued approved waiver orders. On December 1,2007, Uganda, the first country to issue such a waiver order, was oneof the first countries in the world -- and the first country inAfrica -- to receive the lower-strength tablets. The UgandanGovernment's early approval of the waiver allowed Dr. Victor Musiimeof the Joint Clinical Research Centre in Kampala to write the firstprescription for the lower-strength tablet just days after theproduct received marketing authorization in the United States. OtherAfrican governments are now also talking to Abbott about thepossibility of waiver shipments. According to UNAIDS, an estimated110,000 Ugandan children were living with HIV in 2005.
The WHO recommends lopinavir/ritonavir as the preferred treatmentfor children who no longer respond to first-line HIV medicine. TheU.S. Department of Health and Human Service recommendslopinavir/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 inSeptember 2000 in the United States. For pediatric patients,lower-strength Kaletra tablets will offer more dosing flexibility andcontains 100mg of lopinavir and 25mg of ritonavir, compared with theoriginal 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 developingworld firmly in mind when making decisions about the development,manufacturing and delivery of our innovative product," said ScottBrun, M.D., divisional vice president, infectious diseases, GlobalPharmaceutical Research and Development, Abbott. "We have beenaddressing the growing epidemic of HIV in children for more than adecade 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 andshared responsibility. Abbott is committed to working withgovernments, multilateral organizations, nongovernmentalorganizations (NGOs) and civil society to expand access to HIV/AIDStreatments around the world. Abbott has also made significantinvestments in expanding manufacturing capacity to meet the growingdemand for HIV treatment in developing countries.
Abbott's lopinavir/ritonavir formulations are among thelowest-priced protease inhibitors in the developing world. Abbott hasbeen providing its HIV medicines at a price of US$500 per adultpatient per year in all African and least developed countries (LDCs)since 2002, making these medicines more affordable than any genericcopies.
Abbott and Abbott Fund have invested more than US$100 million inthe fight against HIV/AIDS in Africa and the developing world. AbbottFund-supported programs have served more than 600,000 children andfamilies. In addition, more than 250,000 patients have been testedthrough Abbott Fund supported voluntary counseling and testingprograms, with thousands being referred to treatment programs.
Abbott and Abbott Fund have also announced several efforts toexpand access to treatment and care for children living withHIV/AIDS, including an additional investment of US$12 million ingrants 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 tocreate healthier global communities by investing in creative ideasthat promote science, expand health care and strengthen communitiesworldwide.
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 of15 were living with HIV/AIDS worldwide; a vast majority -- 2 millionchildren with HIV/AIDS -- was living in Africa. Last year alone, anestimated 530,000 children were infected with HIV, and 380,000children 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 13were living with HIV/AIDS in the United States. While the number ofpediatric AIDS cases has decreased overall in the U.S., the riskamong African-American and Hispanic infants and children is ofspecial concern. Among U.S. children living with AIDS, 63 percent areAfrican-American, 21.6 percent are Hispanic, and 14.2 percent areCaucasian.
For more information about our commitment to fighting HIV/AIDS,please visit our Web site at http://www.abbott.com/hiv.
Indication and Important Safety Information forlopinavir/ritonavir Indication
Kaletra is indicated for the treatment of HIV-1 infected adultsand children above the age of two years. It is used in combinationwith other antiretroviral agents.
Kaletra does not cure HIV infection or AIDS and does not reducethe risk of passing HIV to others.
Kaletra Important Safety Information
Globally, prescribing information varies; refer to the individualcountry product label for complete information. For U.S. safetyinformation visit http://www.KALETRA.com. Kaletra should not be takenby patients who have had an allergic reaction to any of itsingredients, including lopinavir or ritonavir, or any of theexcipients, or by patients with severe liver problems.
Taking certain medications with Kaletra could cause serious sideeffects that could be life threatening. Do not take Kaletra withastemizole, terfenadine, midazolam, triazolam, pimozide, cisapride,ergotamine, dihydroergotamine, ergonovine, and methylergonovine,rifampicin, amiodarone, vardenafil and products containing St. John'sWort (Hypericum perforatum).
Medical advice and approval must be sought before Kaletra is takenwith medicines that lower blood cholesterol (e.g. lovastatinorsimvastatin), 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 calciumchannel antagonists, (e.g., felodipine, nifedipine, nicardipine) andmedicines used to correct heart rhythm (e.g., bepridil, systemiclidocaine, 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. Kaletramay interact with erectile dysfunction agents (e.g., sildenafil ortadalafil). Lower doses of these medicines should be prescribed inpatients taking Kaletra. Kaletra may interact with digoxin (heartmedicine); monitoring by a physician is recommended.
Taking Kaletra with certain medicines can cause increased levelsof these other medicines in the body. This could increase or prolongtheir effects and/or adverse reactions, which may result in seriousor life-threatening problems. Because of this, patients must telltheir doctor about all medicines they are taking or planning to take,including those medicines that can be bought without a prescriptionand herbal preparations.
Patients using an oral contraceptive or using a patchcontraceptive to prevent pregnancy should use an additional oralternative type of contraception since Kaletra may reduce theeffectiveness of these products.
Pregnant or nursing mothers should not take Kaletra unlessspecifically directed by their doctor.
Kaletra oral solution contains 42 percent alcohol. While takingKaletra oral solution, patients should not take any medicines thatmay 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 takingKaletra. Liver problems, which can be fatal, have also been reported.Patients should tell their doctor if they have had liver disease suchas chronic hepatitis B or C as they are at increased risk for severeand potentially fatal liver adverse events. These patients mayrequire blood tests for control of liver function.
Redistribution, accumulation or loss of body fat may occur inpatients receiving combination antiretroviral therapy. Patientsshould contact their doctor if they notice changes in body fat.
In patients taking protease inhibitors, increased bleeding (inpatients with hemophilia type A and B) has been reported.
Combination antiretroviral therapy may cause new cases of diabetesand high blood sugar or worsening of existing diabetes, as well asincreased fats and raised lactic acid in the blood. The long-termrisks for complications due to increases in triglycerides andcholesterol are not known at this time. In addition, large amounts oftriglycerides have been considered a risk factor for pancreatitis.
In some patients with advanced HIV infection and a history ofopportunistic infection, signs and symptoms of inflammation fromprevious infections may occur soon after anti-HIV treatment isstarted. Symptoms of infection should be reported to a doctorimmediately.
Some patients taking combination antiretroviral therapy maydevelop a bone disease called osteonecrosis. Signs and symptoms arejoint stiffness, aches and pains (especially in the hip, knee andshoulder) and difficulty in movement. These symptoms require thatpatients contact their doctor.
In lopinavir/ritonavir lopinavir/ritonavir adult clinical trials,the very commonly reported (>1 out of 10 persons treated) andcommonly reported (less than 1 out of 10 but more than 1 out of 100persons treated) side effects of moderate to severe intensity werediarrhea, insomnia, headache, nausea, vomiting, abdominal pain,abnormal stools, dyspepsia, flatulence, gastrointestinal disorder,rash, lipodystrophy, weakness, and abnormal liver enzymes. This isnot a complete list of reported side effects. In children two yearsof age and older, the safety profile is similar to that seen inadults.
For more information about Kaletra, please consult your localprescribing information.
Kaletra tablets do not require any special storage conditions.
Kaletra oral solution: Store in a refrigerator (2 degrees - 8degrees C). If kept outside of the refrigerator, do not store above25 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 earlyyears of the epidemic. In 1985, the company developed the firstlicensed test to detect HIV antibodies in the blood and remains aleader in HIV diagnostics. Abbott retroviral and hepatitis tests areused to screen more than half of the world's donated blood supply.Abbott has developed two protease inhibitors for the treatment ofHIV.
Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticalsand medical products, including nutritionals, devices anddiagnostics. The company employs 65,000 people and markets itsproducts in more than 130 countries.
Abbott's news releases and other information are available on thecompany's Web site at http://www.abbott.com. For more information onAbbott's HIV/AIDS programs, please visithttp://www.abbott.com/HIVAIDS and http://www.abbottglobalcare.org.
Web site: http://www.abbott.com
ots Originaltext: Abbott LaboratoriesIm Internet recherchierbar: http://www.presseportal.de
$story.getcontactHeadline()Asia, North America and Latin America, Susan Beverly, +1-847-935-9096, or Europe and Africa, Dirk van Eeden, +1-847-224-1828, both of Abbott
In Zusammenarbeit mit Medizinfuchs
Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA