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Darunavir/cobicistat (PREZCOBIX™) approved by U.S. Food & Drug Administration

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Paul Clift
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Darunavir/cobicistat (PREZCOBIX™) approved by U.S. Food & Drug Administration
Posted on: January 30 2015, 07:55 am

For info, this press release from Janssen about the new fixed-dose combination darunavir/cobicistat:

TITUSVILLE, N.J., Jan. 29, 2015 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved PREZCOBIX™ (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.[1]

PREZCOBIX™ is a once-daily, fixed-dose antiretroviral combination tablet containing 800 mg of darunavir, marketed as PREZISTA® in the United States, and 150 mg of cobicistat, a pharmacokinetic enhancer or "boosting" agent, developed and marketed as Tybost® by Gilead Sciences, Inc., taken orally with other HIV-1 medications and with food.

"Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease," said Karen Tashima, M.D., professor of medicine in the Division of Infectious Diseases, Brown University, director of HIV Clinical Studies, Miriam Hospital, and a lead investigator in the GS-US-216-0130 study. "This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen."

The FDA approval was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents (TMC114IFD1003) and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations (GS-US-216-0130).

The efficacy of PREZCOBIX™ is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir and pharmacokinetic trials showing similar exposures of darunavir when boosted with cobicistat compared to darunavir boosted with ritonavir. Two Phase 3 studies in the darunavir clinical development program, ARTEMIS (TMC114-C211) and ODIN (TMC114-C229), studied the once-daily use of darunavir co-administered with ritonavir.

In the GS-US-216-0130 study, which was conducted with darunavir 800 mg and cobicistat 150 mg administered as single entities in 313 HIV-infected patients, adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials with darunavir co-administered with ritonavir 100 mg. During the darunavir clinical development program, where darunavir was co-administered with ritonavir 100 mg once or twice daily, the most common adverse reactions (incidence greater than or equal to 5 percent) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting.[1]

About PREZCOBIX™
PREZCOBIX™ (darunavir/cobicistat) tablets is a prescription medicine indicated for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). It combines the protease inhibitor darunavir (marketed as PREZISTA® in the United States) with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences, Inc., and marketed as Tybost®, for use in combination with other HIV-1 medications taken orally with food.

WHAT IS PREZCOBIX™?

PREZCOBIX™ is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX™ contains the prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat).
It is not known if PREZCOBIX™ is safe and effective in children under 18 years of age.
When used with other antiretroviral medicines to treat HIV-1 infection, PREZCOBIX™ may help:
reduce the amount of HIV-1 in your blood. This is called "viral load."
increase the number of CD4+ (T) cells in your blood that help fight off other infections.
PREZCOBIX™ is always taken in combination with other HIV medications for the treatment of HIV-1 infection in adults. PREZCOBIX™ should be taken once daily with food.
PREZCOBIX™ does not cure HIV-1 infection or AIDS, and you may still experience illnesses associated with HIV-1 infection. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

The most common side effects of darunavir, one of the medicines in PREZCOBIX™, include diarrhea, nausea, rash, headache, stomach area (abdominal) pain, and vomiting.
             
Other possible side effects include:
High blood sugar, diabetes or worsening diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZCOBIX™.
Changes in body fat can happen in people who take HIV-1 medicines. The exact cause and long-term health effects of these changes are not known.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
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