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news.Janssen Research & Development has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor developed by Janssen R&D Ireland and marketed as PREZISTA in the US, with cobicistat, an investigational pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences for use in combination with other human immunodeficiency virus (HIV-1) medicines.
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Once-daily PREZISTA is indicated for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. PREZISTA is always taken with and at the same time as ritonavir, a boosting agent, with food and in combination with other HIV medicines.
If approved, the fixed-dose combination tablet will be marketed under a new brand name and will, for the first time, offer an additional therapeutic option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir.
In June 2011, Janssen announced a license agreement with Gilead for the development and commercialization of a once-daily tablet fixed-dose combination product of darunavir and Gilead’s cobicistat.
Under the terms of the agreement, Janssen R&D Ireland and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the darunavir and cobicistat fixed-dose combination worldwide. Gilead will retain sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
Janssen infectious diseases and vaccines therapeutic area head Dr Johan van Hoof noted that Darunavir is the most prescribed HIV protease inhibitor in the US 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.
"This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease," Dr Hoof added.
PREZISTA (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. PREZISTA is always taken with and at the same time as ritonavir (Norvir), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA should also be taken with food.