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European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naive Adults With HIV-1
Date:11/27/2008

CORK, Ireland, November 27 /PRNewswire/ -- The Committee for Human Medicinal Products (CHMP) has issued a positive opinion recommending approval for once-daily dosing of 800 mg PREZISTA(R) (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naive adults (those who have never taken HIV medication before). Darunavir, a protease inhibitor, was developed by Tibotec Pharmaceuticals, and Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.

The positive opinion from the CHMP, the committee responsible for the scientific assessment of new medicinal products, will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.

The CHMP's positive opinion is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomised, controlled, open-label phase III trial ARTEMIS in antiretroviral treatment-naive HIV-1-infected adults. Patients received 800 mg darunavir once daily with 100 mg ritonavir as part of combination therapy.

Darunavir, co-administered with low dose ritonavir, is currently indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI). Darunavir was given conditional approval by the European Commission in February 2007. The full marketing authorisation from the European Commission for treatment-naive adult patients is expected in the coming months.

Important Safety Information

In the registrational studies, darunavir was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported in patients who initiated therapy with darunavir 600 mg co-administered with 100 mg ritonavir twice daily were mild to
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SOURCE Tibotec Pharmaceuticals
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