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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
Date:1/28/2008

n, 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 i
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