Tibotec gets conditional approval to sell HIV drug

A conditional marketing authorization was granted to Prezista because of its benefits for HIV-1 infected patients, however, more evidence is yet to be provided. Additional safety and efficacy data will need to be submitted to the European Medicines Agency annually until full authorization is granted.

Tibotec said the timing of the availability of the product will be decided in discussions with national authorities and will vary from country to country.

Prezista, co-administered with 100mg ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor.

“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,” said Professor Margaret Johnson, chair of the British HIV Association executive committee.