FDA approves new
protease inhibitor

U.S. health officials on Friday approved a new HIV protease inhibitor made by Tibotec/Johnson & Johnson that will be used in combination with related therapies to help treat patients who do not first improve with other treatment. The drug, Prezista, is designed to treat drug-resistant strains of HIV.

Also known as TMC114, the drug is given with a low dose of an older protease inhibitor called ritonavir, which slows the breakdown of Prezista in the body, increasing its concentration in a patient's system, the Food and Drug Administration said. While many HIV therapies are now available, AIDS specialists and activists have said resistance to them is becoming a problem because the virus can quickly mutate and current drugs can become ineffective.

The FDA said it approved Prezista based on two six-month trials that found 70% of patients who had tried other therapies improved when they added Prezista and ritonavir to their drug cocktails compared with 21% of those who took ritonavir with other protease inhibitors.

In a separate release, Roche said the trial showed that its anti-HIV drug Fuzeon, in combination with Prezista and ritonavir, resulted in undetectable virus levels in up to two thirds of patients who had become resistant to other drugs.

Side effects of Prezista can include diarrhea, nausea, and headache as well as mild to serious skin rashes. The risks for patients who have not undergone other treatments first is unknown, the agency said.

Prezista is the first of three advanced compounds in J&J's HIV franchise, which aims to combat HIV drug resistance. J&J said the drug, which will be taken in combination with other anti-HIV drugs, will have a wholesale cost of $25 a day. JP Morgan analyst Michael Weinstein, in a note to clients on Wednesday, forecast Prezista sales of $65 million in the second half of 2006 and peak sales of $800 million to $900 million. (Reuters)