CHMP recommends approval of Prezista

Irish drugmaker Tibotec Pharmaceuticals says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has recommended the approval of Prezista (darunavir) in the treatment of HIV. The firm explained that the proposed multidrug therapy, in which the agent is administered in combination with 100mg of ritonavir, is intended for highly pre-treated HIV-1 infected patients who have failed one or more protease inhibitor-based therapeutic regimens.

The CHMP's decision is based on safety and efficacy data from the pooled POWER 1 and 2 studies, which were Phase II dose-ranging examinations. These identified that twice-daily Prezista 600mg plus 100mg of ritonavir was the most appropriate regimen. The company added that the combined therapy is currently in Phase III studies, in which it is being compared with lopinavir/ritonavir in both treatment-experienced (TITAN) and treatment-naive (ARTEMIS) HIV-1 infected patients.

Julie McHugh, company group chair at Tibotec, said that the firm would continue to work closely with the EMEA to ensure that the drug is made available for the increasing number of European HIV sufferers who have experienced failed prior anti-protease-based therapy.