The Food and Drug Administration approves Prezista (darunavir), a new drug for adults with HIV who are not responding to treatment with other antiretroviral drugs. Prezista is a new HIV protease inhibitor that the FDA approved for use with a low-dose of ritonavir and other active anti-HIV agents. Ritonavir is a protease inhibitor that slows the breakdown of Prezista in the body, increasing its concentration in the patient's system.

The FDA says in a statement that infection with HIV causes AIDS, which results in more than 15,000 premature deaths each year in the United States and more than 2.8 million deaths each year worldwide.

Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs says, "This approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health." He adds, "This drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease."

The FDA's accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Prezista-ritonavir combination with other ritonavir-boosted protease inhibitor combinations.