CPMP Positive On Roche's Invirase

Hoffmann-La Roche's proteinase inhibitor Invirase (saquinavir) last month received a positive opinion from the European Union's Committee for Proprietary Medicinal Products. Roche said it will now work closely with the European Medicines Evaluation Agency and the European Commission to ensure a rapid translation of this opinion into a marketing authorization for the EU.

Invirase, said to be the first of a new class of agents, provides a new treatment option for patients suffering from HIV. It has already been approved in several countries, including Switzerland, the USA, Canada, Brazil and Australia.

The drug's clinical development program comprised around 5,000 patients and, additionally, some 12,000 patients have received the drug in a worldwide compassionate supply program. It is also being tested in combination with zalcitabine.