Johnson & Johnson’s new HIV drug Prezista has received conditional marketing approval in the European Union, with the regulatory authorities asking for more data.

J&J’s Tibotec Pharmaceuticals unit says that Prezista (darunavir, formerly TMC114) a protease inhibitor for the treatment of HIV-1 infected patients, is now authorised for use in all 27 EU member states when taken in combination with ritonavir and other antiretroviral medicinal products. However, additional safety and efficacy data will need to be submitted to the European Agency for the Evaluation of Medicinal Products annually until traditional approval for the drug will be considered.

Tibotec spokesman Hans Vanavermaete told PharmaTimes World News that the EU green light, as well as the US approval gained for Prezista last June, was based on “excellent” Phase IIb data from the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies involving 255 treatment-experienced adults, supported by a 24-week analysis of the open label trials (POWER 3 analysis) of 327 patients.

He noted that Prezista is currently in Phase III trials in treatment-naïve (ARTEMIS) and less treatment-experienced patients (TITAN) versus Abbott Laboratories’ Kaletra (lopinavir/ritonavir). Daraunavir is also in Phase III studies (DUET 1 and 2) with an investigational non-nucleoside reverse transcriptase inhibitor, TMC125, in heavily treatment-experienced patients.

Prof Margaret Johnson, chair of the British HIV Association, said that finding additional therapy options for highly treatment-experienced patients “is one of the greatest challenges in HIV care today, as many of these people are currently on treatments which, are either failing or have already failed.” She added that “the data presented so far is promising and Prezista will provide a vital new option for these patients.”

The Prezista approval was also welcomed by Roche which said that it “provides physicians with the opportunity to build a potent new treatment combination” with the firm’s Fuzeon (enfuvirtide). The Swiss major said such a combo has been shown to give treatment-experienced patients a better chance of achieving an undetectable viral load than boosted darunavir without Fuzeon and “this crucial goal of therapy is associated with a better outlook but has for a long time been considered an unrealistic goal.”

Prezista will complete with Boehringer Ingelheim's Aptivus (tipranavir).