Abbott applies for once-daily license for lopinavir/r
Abbott Laboratories has submitted a supplemental New Drug Application to both the US Food and Drug Administration (FDA) and a Marketing Authorisation variation to the European Medicines Agency (EMA), seeking approval of once-daily dosing for its protease inhibitor (PI) Kaletra (lopinavir/ritonavir).
The submission package includes data from a clinical study in which once-daily Kaletra had comparable efficacy to twice-daily Kaletra, both dosed in a regimen containing tenofovir and emtricitabine, in treatment-naïve patients.
Among patients who participated in the study submitted, Kaletra was generally well tolerated. In the 48-week study comparing a Kaletra once-daily vs. twice-daily based antiretroviral regimen, the most frequent drug-related adverse events of moderate or greater intensity reported were diarrhoea and nausea.
Diarrhoea was reported more frequently in patients on once-daily therapy (16%) versus patients on twice-daily therapy (5%).
Source: Abbott press release