PREZCOBIX Approved By FDA

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PrzCobixToday the FDA approved Janssen Therapeutics combination HIV antiretroviral, PREZCOBIX which is a combination of darunavir 800mg and cobicistat 150mg.

PREZCOBIX is indicated for the treatment of HIV-1 in combination with other antiretroviral agents for adults with no darunavir associated resistance mutations.

PREZCOBIX is a once a day fixed dose combination tablet and is the second cobicistat containing protease inhibitor combination to be approved in as many days, with the FDA approving EVOTAZ yesterday.

Cobicistat is a CYP3A4 boosting agent manufactured by Gilead Sciences under the brand name Tybost.

The FDA based its approval on data finding that using Prezcobix was equivalent to taking darunavir and cobicistat separately, and on another study that tested the safety of the combination tablet among those whose virus had no resistance mutations to darunavir.

Research showed that drug levels of darunavir were similar whether the drug was boosted with ritonavir or darunavir.

The GS-US-216-0130 study gave darunavir and cobicistat as individual tablets to 313 HIV-positive participants. After 24 weeks of treatment, the participants did not have substantially different adverse reactions to the combination when compared with people who took darunavir and ritonavir in other trials.

“Treating HIV remains an urgent healthcare need, and it’s important for adults living with HIV to have regular discussions with a healthcare provider about treatment options that are right for them,” said Richard Nettles, MD, Vice President of Medical Affairs at Janssen Therapeutics, in a press release. “The approval of Prezcobix exemplifies Janssen’s ongoing commitment to developing new treatment options for those living with HIV and builds upon the legacy of darunavir.”

Karen Tashima,MD professor of medicine in the Division of Infectious Diseases at Brown University and director of HIV Clinical Studies at Miriam Hospital said, “Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease. This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen.”

 

READ THE FULL PRESS RELEASE HERE

DOWNLOAD THE PRODUCT MONOGRAPH HERE