Pediatric HIV drug approved by EU committee

February 1, 2008
Jeff Ryan

A child-size dose of an HIV drug is one step closer to being available in Europe...

A child-size dose of an HIV drug is one step closer to being available in Europe.

The drug, Abbott's lopinavir/ritonavir (Kaletra), is already available in an adult dose of 200 mg/50 mg, respectively. The halved pediatric dose, 100 mg/25 mg, has already been approved by FDA.

The EU's Committee for Medicinal Products of Human Use, which works with the World Health Organization, approved the new dosage. The approval brings with its a Certificate of Pharmaceutical Product, which lets the new dosage to be approved in many developing countries. Abbott markets Kaletra at a reduced price in developing countries as Aluvia.

Both the old and new dosages do not need refrigeration, and can be taken with or without food. EMEA (European Medicines Agency) approval of the drug is expected within 90 days.