Kaletra lopinavir/ritonavir regulatory update

The FDA granted accelerated marketing approval for Kaletra in capsule and liquid formulations to treat HIV infection in adults and in children ages six months and older in combination with other antiretrovirals. The approval is based on viral load and CD4 T cell data from a 24-week Phase III trial and separate 72-week studies. ABT said full approval will require additional Phase III safety and efficacy data. Kaletra also is under review in Europe, Canada and elsewhere. ...