Abbott’s HIV tablet for paediatric use receives positive CHMP opinion

Abbott has announced that Kaletra and Aluvia (lopinavir/ritonavir), its new lower-strength co-formulated protease inhibitor tablet for use in children with HIV, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

This lower-strength formulation has been described by the firm as a breakthrough for doctors and patients in developing nations as the tablets do not require refrigeration and do not have to be taken with a meal.

Following the review of the positive CHMP opinion by the European Commission, a final decision for marketing authorisation for the compound in the EU will be made in the next two to three months.

Mark Kline, professor of paediatrics, chief of retrovirology and director of the AIDS International Training and Research Programme, said: “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.”

He added that the development of this treatment marks significant progress in the care of patients in settings with limited resources.

In July 2007, Abbott announced that Aluvia had been approved for use in 19 countries in Africa, including Burundi, Rwanda and Zambia.