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.

The new Prestiza with cobicistat is designed for use in patients with HIV-1 who are treatment-experienced as well as those who have never undergone treatment before and who additionally do not exhibit darunavir resistance-associated mutations.

HIV and AIDS currently affect more than 1.1 million people in the United States, and about 33.4 million people wordwide. In the U.S., as many as 1 in 6 is unaware of their infection, and it’s estimate that there are more than 50,000 new cases of HIV infection each year.

Of the two strains, HIV-1 is the more prevalent form of HIV, although both types are spread through sexual contact as well as from mother to child. HIV-2 affects a much smaller population worldwide and is concentrated primarily in West African nations; it was originally discovered in Cameroon in 1998 and is considered extremely rare.

Gilead Sciences Inc. is currently industry leader and largest maker of HIV and AIDs drugs. In December, the FDA approved a single-tablet, once-daily HIV-1 treatment Complera, which is designed for the treatment of virologically-suppressed adult patients who are already on a stable antiretroviral treatment regimen.

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