April 1, 2014
Janssen Files for Approval of Single-Pill Prezista & Cobicistat
Janssen Research & Development has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for a once-daily fixed dose combination tablet of two HIV antiretrovirals (ARVs): the company’s Prezista (darunavir) and Gilead Sciences’ cobicistat. Prezista is a protease inhibitor, and cobicistat is an investigational pharmacokinetic enhancer, also known as a boosting agent, that, like Norvir (ritonavir), can increase the level of absorption into the blood of other ARVs and thus make them more effective.
Prezista is already FDA approved for the treatment of HIV-1 in both treatment-naive and treatment-experienced adults who have no resistance mutations to the drug. Since June 2011, Janssen has been working under a licensing agreement with Gilead to develop this new combination pill. If the tablet is approved, it will be marketed under a new name.
“[Prezista] 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 of infectious diseases and vaccines at Janssen, said in a release. “This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease.”
To read the Janssen press release, click here.
Search: Janssen, Gilead Sciences, New Drug Application, Prezista, darunavir, cobicistat, Norvir, ritonavir
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