The European Commission
has granted marketing authorization for the new, lower-strength tablet formulation
of the single-pill, combination protease inhibitor lopinavir/ritonavir.
The tablet can be taken with or without food and does not require refrigeration.
Lopinavir/ritonavir is marketed as Kaletra
in the U.S. and Europe, and as Aluvia in developing countries and as.
 |
Kaletra
Tablet |
 |
Children
with HIV/AIDS
(UNAIDS) |
Currently,
the lower-strength tablet is available or approved in 53 countries in Europe,
Africa, Asia, Latin America, and North America. Abbott, the maker of lopinavir/ritonavir,
has filed for marketing approval 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. Abbott intends to make the lower-strength tablet available in 155 countries
around the world, just as it has done with the adult tablet.
"The
lower-strength [lopinavir/ritonavir] formulation is the first and only coformulated
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, MD, Department of Pediatrics, University of Padua, Italy, and Chair
of the Pediatric European Network for Treatment of AIDS (PENTA).
The
lower-strength lopinavir/ritonavir tablet offers HIV positive children new benefits
not available with the current soft capsules or oral solution, enhancing dosing
convenience without compromising efficacy:
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 in Africa -- to receive
the lower-strength tablets. According to the Joint United Nations Programme on
HIV/AIDS (UNAIDS), an estimated 110,000 Ugandan children were living with HIV
in 2005. Other African governments are now also talking to Abbott about the possibility
of waiver shipments.
The
World Health Organization (WHO) recommends lopinavir/ritonavir as the preferred
treatment for children who no longer respond to first-line HIV medications. The
U.S. Department of Health and Human Service (DHHS) recommends lopinavir/ritonavir
for the initial treatment of children with HIV.
4/11/08
Source
Abbott
Laboratories. New Abbott Kaletra (lopinavir/ritonavir) Lower-Strength Tablet for
Pediatric Use Approved in Europe. Press release. April 7, 2008.
