Abbott receives approval for low-strength Kaletra

Abbott has announced that it has received marketing authorisation for a lower-strength tablet formulation of Kaletra (lopinavir/ritonavir) from the European Commission.

The tablet is the first co-formulated protease inhibitor tablet approved for use in children with HIV, does not require refrigeration and can be taken with or without refrigeration.

Abbott notes that this approval is a vital step in its work to speed up registration across the world, including in developing countries.

Lopinavir/ritonavir is recommended by the World Health Organisation as a preferred treatment for children who no longer respond to first-line HIV medication, while the US department of health and human service recommends the drug for the initial treatment of children with HIV.

Scott Brun, divisional vice-president of infectious diseases in global pharmaceutical research and development at Abbott, said: “HIV/Aids continues to have a devastating effect on millions of children around the world, especially those patients living in resource-limited settings.”

He added that the availability of a lower-strength dose of Kaletra is another example of the company’s dedication to improving treatment for those affected by the disease.

In July 2007, Abbott reduced the price charged for Kaletra in Brazil by 29.5 per cent, Reuters reports, with the Brazilian government calling on the rest of the industry to follow this example.