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Janssen submits NDA for darunavir/cobicistat combination tablet for HIV
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Janssen is seeking FDA approval for a once-daily, fixed-dose antiretroviral combination tablet that contains the protease inhibitor darunavir and the investigational boosting agent cobicistat for use in combination with other drugs to treat HIV-1 infection in adult patients, according to a news release from the manufacturer.
Darunavir (Prezista, Janssen) is indicated for the treatment of HIV-1 in both treatment-naive and experienced adult patients. Darunavir is taken at the same time as the boosting agent ritonavir (Norvir, AbbVie), but FDA approval of the new fixed-dose tablet will reduce the number of drugs needed for treatment. If approved, the drug will be marketed in the US under a new 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,” Johan van Hoof, MD, therapeutic area head, infectious diseases and vaccines, Janssen, said in the release. “This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease.”
Although cobicistat was developed by Gilead, Janssen will be responsible for marketing the new formulation under a license agreement between the two companies.