Boehringer Ingelheim today announced that the European Commission has given the full marketing authorisation to its HIV protease inhibitor (PI), Aptivus (tipranavir).
The Commission has fully approved Aptivus for the suppression of HIV in highly treatment experienced patients who have developed resistance to other protease inhibitors.
Resistance to HIV therapies is a considerable problem, with an increasing number of people developing strains of HIV that are resistant to protease inhibitors. For example, in one study in the UK 27% of treatment-experienced patients demonstrated resistance against protease inhibitors and in Spain, 43% of patients treated for more than eight years carry more than five protease resistance mutations.
Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine said: “We welcome this decision by the EU Commission to grant full marketing authorisation for Aptivus. This full approval demonstrates the confidence that the authorities have in the benefit of Aptivus for patients with resistant virus.”
Aptivus, the first non-peptidic protease inhibitor, shows good antiviral activity against viruses that have shown decreased susceptibility to other currently marketed PIs.
The decision to grant full marketing authorisation was taken on the evidence of two large multicentre pivotal trials (RESIST I and II) demonstrating Aptivus’ superiority across several efficacy measures to a group of comparator PIs boosted with ritonavir. Treatment response rates over 156 weeks were almost three times higher in the Aptivus arm compared to the comparator arm (20.9% against 7.5%) and were markedly higher for those patients who also started a new class of HIV therapy (Enfurvitide).