J&J Seeks FDA Approval for New HIV Therapy

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Johnson & Johnson‘s (NYSE:JNJ) Janssen Pharmaceuticals Inc. is hoping to gain approval for a new HIV treatment, a fixed-dose, once-daily antiretroviral drug that is being marketed as Prestiza in the U.S., according to a press release Tuesday.

Prestiza contains both darunavir, a protease inhibitor developed by Janssen’s research and development team in Ireland, and cobicistat, which is an investigational boosting agent that was developed by Gilead Sciences Inc. (NASDAQ:GILD) for use in combination with other HIV medicines.

Darunavir is already a successful HIV treatment on the market, but the new drug, which also contains Gilead’s cobicistat, will eliminate the need to take a boosting agent in a separate tablet, as the two are combined. If the new combined tablets are approved, Janssen will market the drug under a different brand name.

“Darunavir is the most prescribed HIV protease inhibitor in the United States, and we are excited to be taking this important step in our efforts to offer it with an alternative boosting agent in a fixed-dose combination tablet,” said Johan van Hoof, an M.D. who serves as the Therapeutic Area Head for the Infectious Diseases and Vaccines division at Janssen.

“This filing demonstrates our ongoing commitment to develop HIV treatment options and fixed-dose treatment regimens for those living with the disease,” van Hoof continued in a Janssen press release.

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