Janssen Files NDA For New HIV Combo Drug

Janssen Research & Development (Janssen) announced that it has filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose antiretroviral combination tablet containing its protease inhibitor Prezista (darunavir) with Gilead Sciences’ cobicistat, an investigational pharmacokinetic enhancer for use in combination with other human immunodeficiency virus (HIV-1) medicines.

Prezista is a prescription medicine and treatment option in the class of HIV treatments known as protease inhibitors. The drug should be taken with and simultaneously with ritonavir, in combination with other HIV treatments. Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor designed to boost blood levels of atazanavir and darunavir through suppression of CYP3A, an enzyme that metabolizes these drugs in the body. The drug only works as a pharmacokinetic enhancer and has no antiviral activity.

If approved, the fixed-dose combination tablet will be commercialized under a new brand name. Janssen said that it will also offer an additional therapeutic option that crosses out the need for administration of a boosting agent in a separate tablet with once-daily darunavir.

Johan van Hoof, Therapeutic Area Head of Infectious Diseases and Vaccines at Janssen, said, “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. This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease.”

In June 2011, Janssen entered into a license agreement with Gilead for the development and marketing of a once-daily tablet fixed-dose combination product of darunavir and cobicistat. Janssen R&D Ireland and affiliates retain global rights to darunavir and cobicistat while Gilead retains sole rights to cobicistat as a stand-alone product and for use in combination with other agents.