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J&J Anti-HIV Drug Wins Accelerated FDA Approval

Posted on: Monday, 26 June 2006, 12:00 CDT

The FDA has granted accelerated approval for the use of Johnson & Johnson's anti-HIV medication Prezista as part of combination therapy for the disease.

Prezista, co-administered with 100mg ritonavir (Prezista/rtv) and with other antiretroviral agents, is indicated for the treatment of HIV infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

The drug was developed by Tibotec Pharmaceuticals on behalf of Johnson & Johnson - its parent company.

FDA accelerated approval procedures allow for earlier approval of drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases.

This approval is based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of two studies. Longer-term data will be required before the FDA can consider traditional approval for Prezista.

"One of the greatest challenges in HIV care is finding therapies for treatment-experienced patients," said Dr Michael Saag, director of the AIDS Outpatient Clinic and the University of Alabama at Birmingham Center for AIDS Research. "This is an important new option for the thousands of people with HIV in the US who are resistant to more than one protease inhibitor."

Source: Datamonitor

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