WASHINGTON – A new drug to treat HIV won federal approval Friday. The Food and Drug Administration said it approved Prezista for the treatment of the human immunodeficiency virus.
The drug is the first approved HIV medication for its maker, Johnson & Johnson. It's also the first new HIV drug approved since June 22, 2005.
The drug, also known as darunavir, is a member of the protease inhibitor class of drugs. They work by blocking protease, a protein the virus needs to make more copies of itself. Since 1995, FDA has approved 10 other protease inhibitors.
The major side effects of this class of drugs are high cholesterol and blood-sugar levels, as well as lipodystrophy, or the redistribution of body fat. Protease inhibitors typically are taken as part of a cocktail of drugs.
Prezista is meant for use in patients who don't respond to treatment with other antiretroviral drugs, the FDA said.
The risks and benefits of Prezista for adults who haven't previously been treated for HIV and children are unclear, the FDA said.
The FDA approved Prezista to be taken with a low-dose of Norvir, a protease inhibitor made by Abbott Laboratories, in combination with other HIV drugs, the FDA said. Norvir, also called ritonavir, slows the metabolism of Prezista, boosting its effect.
In return for the FDA's accelerated approval of the drug, J&J must conduct follow-up trials to determine the drug's benefits, as well as to study its use in children.
Prezista — taken as two pills, twice daily — will cost $25 a day, according to J&J unit Tibotec Therapeutics.