April 7, 2008 — Abbott announced today that it has received marketing authorization from the European Commission for the new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, Kaletra® (lopinavir/ritonavir). The Kaletra tablet can be taken with or without food and does not require refrigeration. Lopinavir/ritonavir is marketed as Aluvia® in developing countries.
European approval is a critical step in Abbott's efforts to expedite registration filings for the lower-strength tablet formulation in countries around the world, including in developing countries where more than 2 million of the estimated 2.3 million children worldwide with HIV/AIDS live. In Europe, there are approximately 4,000 children living with HIV.
Currently, the lower-strength tablet is available or approved in 53 countries in Europe, Africa, Asia, Latin America and in North America, and is filed in an additional 11 countries. European Commission approval is significant for many developing countries because they require documentation of the marketing authorization to obtain 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. Abbott intends to make the lower-strength tablet available or approved in 155 countries around the world, just as it has done with the adult tablet.
"The lower-strength Kaletra formulation is the first and only co-formulated protease inhibitor tablet that can be used in children of appropriate age, weight or body surface area, representing a significant breakthrough for clinicians treating children with HIV in both developed and developing countries," said Carlo Giaquinto, M.D., Department of Pediatrics, University of Padua, Italy, chair of PENTA (Pediatric European Network for Treatment of AIDS).
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