The US Food and Drug Administration on Friday approved Prezista (darunavir), a new drug for adults whose HIV infection hasn't responded to treatment with other antiretroviral drugs.
Prezista, a new protease inhibitor, is approved to be used with a low-dose of ritonavir and other active anti-HIV agents. Ritonavir, a protease inhibitor approved in 1996, slows the breakdown of Prezista in the body, increasing the concentration of Prezista in the patient's system, the FDA said.
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.
"This approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health," said Dr Andrew C. von Eschenbach, acting FDA commissioner. "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 most common side effects of the Prezista-ritonavir regimen include diarrhoea, nausea and headache. The risks and benefits of Prezista have not been established for adults who have not been previously treated for HIV, or for children, the FDA said.- (HealthDayNews)