The new HIV protease inhibitor darunavir, sold by Johnson & Johnson under the trade name Prezista, received conditional marketing approval in the European Union for all 27 member states, a unit of the company said on Friday.
Prezista is used in combination with other antiretroviral drugs to treat resistant strains of HIV in patients who do response to first-line regimens.
Additional safety and efficacy data will need to be submitted annually until full authorization is granted, said Johnson & Johnson unit Tibotec Pharmaceuticals. The product's availability in individual EU countries will be decided with national authorities.
Prezista received U.S. approval in June, making it Johnson & Johnson's first protease inhibitor to hit the market.
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