| Prezista Receives U.S. FDA Approval |
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The U.S. FDA has granted accelerated approval to the anti-HIV medication Prezista. It is a protease inhibitor that was developed by Tibotec Pharmaceuticals. The accelerated approval program allows for early approval of drugs that “provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases”. Another HIV drug, Atripla was also approved under the program. The approval is based on a 24-week analysis of HIV viral loads and CD4+ cell counts from 2 different studies. For the FDA to consider traditional approval, longer-term data is required. Prezista, which is co-administered with ritonavir 100mg and other antiretroviral agents is indicated for the treatment of HIV infection in patients who have HIV-1 stains resistant to more then one protease inhibitor. The following points should be considered when initiating therapy with Prezista/rtv: • Treatment history and, when available, genotypic or phenotypic testing should guide the use of Prezista/rtv. • The use of other active agents with Prezista/rtv is associated with a greater likelihood of treatment response. • The risks and benefits of Prezista/rtv have not been established in treatment-naïve adult patients or pediatric patients. Martin Delaney of The Fair Pricing Coalition believes that Tibotec Therapeutics has priced Prezista responsibly. Tibotec has committed to putting the needs of patients first by making this product available and accessible to people in the United States living with HIV. To read the entire article, please click here . |
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