Janssen Announces FDA Approval of SYMTUZA

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced on July 18, 2018 that the U.S. FDA has approved the use of SYMTUZA, the only complete darunavir-based singled-tablet regimen (STR) for the treatment of HIV-1 in adults.

SYMTUZA, a one-a-day pill taken with food, capitalizes on the proven high barrier to resistance of darunavir in a formula redesigned for improved tolerability and the convenience of an STR. SYMTUZA is used without other antiretroviral medicines in adults who have not received anti-HIV-1 medicines in the past, or whose healthcare provider determines that they meet certain requirements.

Potential side effects of SYMTUZA include diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas. Further, SYMTUZA should not be taken by women who are pregnant or breastfeeding.

The U.S. Department of Health and Human Services guidelines recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including patients who may have difficulties with regimen adherence or when ARV treatment should be initiated before resistance test results are available. “Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication—or even an entire class of medications—to stop working,” said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C.


For more information about SYMTUZA, log on to https://www.janssen.com.