U.S. FDA Approves New Lower-dose Formulation of Lopinavir/ritonavir (Kaletra) for Children

Treatment for infants and children with HIV remains a challenge. Since most research and development of antiretroviral therapies is done in adults, there is less knowledge about optimal use and fewer drugs available in dose formulations appropriate for children.

On November 12, 2007, the U.S. Food and Drug Administration (FDA) approved a new, lower-dose formulation of Abbott’s boosted protease inhibitor lopinavir/ritonavir (Kaletra in the U.S., Aluvia elsewhere). While a liquid formulation has been available for several years, there will now be a pill with a dose suitable for pediatric patients, in a size that is easier for children to swallow.

The new pill is expected to be available in U.S. pharmacies by the end of this month. Abbott is currently awaiting European approval, and ultimately plans to make the new formulation available in many countries in the developing world, where most HIV-infected children live.

Below is an excerpt from Abbott’s press release announcing the new dose formulation:

Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra (lopinavir/ritonavir) Tablet for Pediatric HIV Patients

Abbott Will Register and Make the New Lower-Strength lopinavir/ritonavir Tablet Available in More Than 150 Countries to Support Broad Access for the More Than 2 Million Children Living with HIV Worldwide

Abbott Park, Illinois, November 12, 2007 -- Abbott today announced that it has received U.S. Food and Drug Administration (FDA) approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir), which is also marketed as Aluvia (lopinavir/ritonavir) in developing countries. The lower-strength Kaletra tablets will be available in the U.S. this month.

Abbott is awaiting EMEA [European Medicines Evaluation Agency] marketing authorization for the Kaletra/Aluvia lower-strength tablets. Upon EMEA marketing authorization, Abbott intends to register this new tablet formulation in more than 150 countries. The soft gel capsule formulation of lopinavir/ritonavir is the most widely registered protease inhibitor in the world. The original tablet formulation is already available in 93 countries and Abbott is awaiting approval in an additional 45 countries for this formulation.

Approval of this lower-strength Kaletra tablet represents an important step in Abbott’s ongoing commitment to the global fight against HIV because:

·    The tablets do not require refrigeration and can be taken with or without a meal -- an important advance in delivering HIV medicine to children in developing countries.

·    The World Health Organization (WHO) estimates 2 million children were living with HIV/AIDS in sub-Saharan Africa at the end of 2006.

·   The new lower-strength tablets are smaller in size than original Kaletra tablets and contain the same proven active ingredients as Abbott’s Kaletra oral solution. The lower-strength Kaletra tablet is approved for children weighing 15 kg or more who are able to swallow the intact tablet.

·   The FDA approval expands available options for using the first and only co-formulated protease inhibitor tablet to treat children with HIV.

"HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world," said Scott Brun, MD, divisional vice president, infectious diseases and renal development, Global Pharmaceutical Research and Development, Abbott. "Abbott developed a lower-strength tablet formulation of Kaletra to give physicians an innovative treatment option to help curb the impact of HIV infection in children."

The price of the recently approved lower-strength tablet will be half the price of the original tablet in the developing world.

About 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 100 mg of lopinavir and 25 mg of ritonavir, compared with the original tablet strength of 200 mg of lopinavir and 50 mg of ritonavir, most commonly used by adults.

The complete version of this press release, including detailed safety information, is available online.

For full lopinavir/ritonavir prescribing information, visit www.kaletra.com.

11/16/07

Source
Abbott Laboratories. Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra (lopinavir/ritonavir) Tablet for Pediatric HIV Patients. Press release. November 12, 2007.