Johnson and Johnson HIV drug receives conditional marketing authorisation

Tibotec Pharmaceuticals, a division of Janssen-Cilag, part of the Johnson & Johnson group of companies, has announced that its anti-HIV medication Prezista (darunavir) has received conditional marketing authorisation in the European Union.

Following analysis of the Power 1 and 2 studies, the European Commission has elected to conditionally authorise the use of the compound in conjunction with ritonavir and other antiretrovirals in all 27 member states, with full authorisation dependent on future safety and efficacy data to be submitted annually.

Prezista, developed by Tibotec, is a protease inhibitor indicated for the treatment of patients infected with HIV-1 and is currently undergoing comparative clinical trials at phase III comparing the compound with Kaletra (lopinavir/ritonavir).

Professor Margaret Johnson, chair of the British HIV Association executive committee, said: “The approval of Prezista marks an important step in the management of highly treatment-experienced patients.”

She added that finding such treatment options is one of the most difficult tasks in the care of HIV patients, with this approval potentially providing a key new therapy option for these patients.

Last August, additional safety and efficacy data for 300 mg tablets of Prezista were presented at the 16th International Aids conference held in Toronto, Canada.