Summaries of health policy coverage from major news organizations
FDA Approves Sale of Protease Inhibitor
FDA on Friday gave accelerated approval to Johnson & Johnson subsidiary Tibotec's application for sale and marketing of its experimental protease inhibitor TMC114, which will be sold under the brand name Prezista, for use by HIV-positive people who are resistant to first-line drugs, the Newark Star-Ledger reports (May, Newark Star-Ledger, 6/24). Protease inhibitors work by blocking the action of an enzyme that cuts HIV proteins into the shorter sections that the virus needs to create copies of itself (Kaiser Daily HIV/AIDS Report, 2/28/05). Phase II clinical trials of TMC114 show that the drug is effective against drug-resistant HIV strains, and the drug lowered viral loads to undetectable levels among nearly half of trial participants (May, Newark Star-Ledger, 6/22). According to Roche, FDA's approval of Prezista could lead to potential new applications for its drug Fuzeon -- known generically as enfuvirtide -- in combination therapy treatments. Roche said that studies have shown up to two-thirds of HIV-positive people had reached undetectable viral levels when taking a combination of Prezista and Fuzeon, AFX/Forbes reports (AFX/Forbes, 6/26). J&J also is conducting a Phase III trial comparing TMC114 with Abbott Laboratories' antiretroviral drug Kaletra (Kang, Forbes, 6/21). Tibotec is required to track the safety of the drug and study its use in children. In addition, J&J is testing Prezista's safety and efficacy for people who previously have not been treated for HIV. Prezista will cost $25 daily (Newark Star-Ledger, 6/24). Common side effects of Prezista include nausea, diarrhea, headache and skin rash (Xinhua News Agency, 6/24). Prezista also is coadministered with 100 mg ritonavir (J&J release, 6/23). Prezista is J&J's first approved HIV drug and is the first new HIV drug approved since June 2005, according to the AP/Houston Chronicle (Bridges, AP/Houston Chronicle, 6/23).
This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.