Abbott announced today that the 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, more convenient tablet formulation of its protease inhibitor (PI) Kaletra(R) (lopinavir/ritonavir). The European Commission decision regarding marketing authorization is expected within 90 days. The anticipated marketing authorization from the European Commission also will enable Abbott to move forward with registration filings and seek approvals in developing countries.
The tablet formulation of Kaletra was developed using the proprietary Meltrex(TM) melt-extrusion technology and is designed to offer patients a number of new benefits not available with the current Kaletra capsules, including:
– Fewer tablets per dose as part of their treatment regimen;
– No required refrigeration, before or after dispensing (unlike the current soft capsule formulation, which requires refrigeration); and
– Can be taken with or without food.
“Abbott has a long legacy of providing innovative treatment options to the HIV community, including improved formulations for existing products,” said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. “As we celebrate 10 years of protease inhibitor availability, which revolutionized HIV therapy, the Kaletra tablet offers the next step in the development of treatments directly tailored to patient needs by providing a more convenient version of the leading prescribed PI for the treatment of HIV in the European Community.”
The positive opinion for the tablet formulation of Kaletra was based upon data from pharmacokinetic studies. Abbott’s tablet submission was filed as a line extension to the EMEA on May 19, 2005. The United States Food and Drug Administration (FDA) approved the Kaletra tablet on October 31, 2005.
The new formulation of Kaletra will provide patients with a tablet composed of 200 mg lopinavir and 50 mg ritonavir, as compared to the current soft capsule, which contains 133.3 mg lopinavir and 33.3 mg ritonavir. While the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, the number of Kaletra pills patients need to take is reduced to four tablets from six soft capsules per day. The standard daily doses of the new tablet formulation and the current capsules provide similar drug levels in the blood.
Abbott’s Commitment to Access
Abbott has taken extensive steps to make the capsule formulations of its HIV medicines, including Kaletra, available throughout the world. Similarly, Abbott is working to register the new tablet formulation in countries around the world as rapidly as possible. Most recently, Abbott filed for registration of the new tablet formulation in South Africa on March 31, 2006, and has been granted fast track review by the Government of South Africa.
Kaletra Safety Information
Kaletra is currently approved by the EMEA in its capsule formulation, and always used in combination with other anti-HIV medicines to treat people with HIV infection. Kaletra should not be taken by patients who have had an allergic reaction to lopinavir/ritonavir or any of its ingredients, including lopinavir or ritonavir.
Taking certain medications with Kaletra could create the potential for serious side effects that could be life threatening. Kaletra should not be taken with astemizole, cisapride, dihydroergotamine, ergonovine, ergotamine, methylergonovine, midazolam, pimozide, terfenadine or triazolam.
In addition, Kaletra should not be taken with fluticasone propionate, lovastatin, rifampin, simvastatin, or products containing St. John’s Wort (Hypericum perforatum). Particular caution should be used when taking Kaletra with sildenafil, tadalafil, or vardenafil. Please consult your local prescribing information for country specific recommendations.
Patients should discuss all medicines, including those without a prescription and herbal preparations they are taking or plan to take, with their doctor or pharmacist.
Pancreatitis and liver problems, which can be fatal, have been reported. Patients should tell their doctor if they have had liver disease such as hepatitis. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred. Changes in body fat have been seen in some patients receiving antiretroviral therapy. Some patients receiving Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.
In Kaletra clinical trials, the most commonly reported side effects of moderate-to-severe intensity were abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, nausea and vomiting. Children taking Kaletra may sometimes get a skin rash. This is not a complete list of reported side effects. Kaletra oral solution contains alcohol.
Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.
More information is available at www.kaletra.com and 1-866-KALETRA.
Abbott (NYSE: ABT) 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. With Kaletra, Abbott has developed two protease inhibitors, and offers nutritional products that meet the unique dietary needs of hundreds of thousands of people living with HIV.
Abbott and the Abbott Fund also are investing $100 million in developing countries to find solutions to underlying barriers to testing, treatment and support services for people living with HIV/AIDS. Through pioneering programs that prevent mother-to-child transmission of HIV, expand access to testing and treatment, strengthen health systems, and provide support for children and families, Abbott has improved the health and lives of millions of people affected by HIV/AIDS.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, device and diagnostics. The company employs 60,000 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.