Boehringer Ingelheim announces European approval of Aptivus

Boehringer Ingelheim has announced that the European Commission has granted full marketing approval to Aptivus (tipranavit), its HIV protease inhibitor.

The compound has been approved for use in Europe for the suppression of HIV in patients who are highly treatment-experienced who have developed resistance to other available protease inhibitors.

Aptivus, which is the first non-peptidic protease inhibitor, has shown strong antiviral activity against viruses have have displayed reduced susceptibility to other protease inhibitors on the market.

Approval for the compound was based on the evidence of the Resist I and Resist II trials that showed the superiority of the drug across several measures of efficacy compared to comparator protease inhibitors boosted with ritonavir.

Dr Andreas Barner, member of the board of Boehringer Ingelheim responsible for research, development and medicine, said: “We welcome this decision by the European Commission to grant full marketing authorisation for Aptivus.”

He added that the approval shows the confidence of the regulatory authorities in the benefit of Aptivus in HIV patients who have developed resistance.

In October 2007, Boehringer Ingelheim announced three-year data from the Resist studies showing that Aptivus in combination with Norvir (ritonavir) is an effective and durable therapy option for treatment-experienced HIV patients.