European regulators have granted full approval to Boehringer Ingelheim’s HIV drug Aptivus, which had previously only been allowed to market it under exceptional circumstances.

The European Commission has given the full marketing authorisation to the firm for Aptivus (tipranavir) for the suppression of HIV in highly treatment-experienced patients who have developed resistance to other protease inhibitors. The drug gained provisional approval in October 2005 and the ‘exceptional circumstances’ restriction has been removed.

The decision to grant full marketing authorisation was taken on the evidence of two large trials (RESIST I and II), involving some 1,400 patients, which demonstrated Aptivus’ superiority “across several efficacy measures to a group of comparator PIs boosted with ritonavir”, Boehringer said. Treatment response rates over 156 weeks were almost three times higher in the Aptivus arm compared to the comparator arm (20.9% vs 7.5%) and were “markedly higher” for those patients who also started a new class of HIV therapy, Trimeris’ fusion inhibitor Fuzeon (enfuvirtide).

Boehringer noted that an increasing number of people are developing strains of HIV that are resistant to PIs. A study in the UK showed that 27% of treatment-experienced patients demonstrated resistance, and in Spain, 43% of patients treated for more than eight years carry more than five protease resistance mutations.

Tipranavir received marketing authorisation from the Food and Drug Administration in June 2005 and was granted traditional approval last October. Sales of the treatment last year reached 45 million euros, down 14.9%.

Encouraging survival rates with Vargatef
The Aptivus news came just after Boehringer presented promising Phase II data suggesting both overall and progression-free survival with Vargatef.

The results, which were presented at the European Lung Cancer Conference in Geneva, showed that monotherapy treatment with Vargatef, a triple angiokinase inhibitor formerly known as BIBF 1120 offers promising efficacy and is well tolerated in patients with advanced, relapsed non-small cell lung cancer. Boehringer claimed that of particular note were results from a subset of 57 patients with ‘good disease state’ who experienced longer overall survival (9.5 months), longer progression-free survival (2.9 months) and a higher stable disease rate of 59% compared with the overall study population.

The drug represents one of the key components in Boehringer’s bid to become a major player in cancer. Head of R&D Andreas Barner said the new data, coupled with evidence from previous studies show that BIBF 1120 is well tolerated in combination with standard lung cancer treatments. “We are making great progress in our oncology research programme”, he added, “and we look forward to presenting further data from our franchise during 2008.”