Abbott's Lower-Strength Tablet For Pediatric Use Welcomed By EMEA

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Tablet For Pediatric Use

European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of a new, lower-strength tablet formulation of Abbott's leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir).

In addition, the CHMP has adopted a positive opinion, in coordination with the World Health Organization (WHO), for Aluvia (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.

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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."

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