– Two-drug regimen could offer many patients the option to switch to a regimen that does not include a nucleotide reverse transcriptase inhibitor –
CORK, Ireland I June 1, 2017 I Janssen Sciences Ireland UC, today announced that ViiV Healthcare has made regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). If approved, this will be the first two-drug regimen for the maintenance treatment of HIV-1 infection and will offer those living with HIV who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI).
The submissions are based on the Phase III SWORD studies which included more than one thousand patients who previously achieved viral suppression on a three or four drug antiretroviral regimen. The data were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in February.
A Priority Review voucher was submitted to the FDA along with the dolutegravir and rilpivirine two-drug regimen New Drug Application (NDA). Under the Prescription Drug User Fee Act, the anticipated target action date is six months after receipt of the application by the FDA.
“People living with HIV have always faced complex treatment regimens and a high pill burden. We know adherence is critically important for treatment outcomes and these regulatory submissions for dolutegravir plus rilpivirine represent a significant step forward in our efforts to deliver the first single-tablet, two-drug regimen for people living with HIV,” said Lawrence M. Blatt, Global Therapeutic Area Head, Infectious Disease Therapeutics, Janssen. “If approved, this novel regimen will offer patients who are virally suppressed a safe and effective treatment option.”
Janssen have brought medicines to market across a range of patient populations that have helped to transform the efficacy and tolerability of treatment. In the US, approximately one in three people are managing their HIV with a treatment regimen containing a Janssen medicine.
Use of dolutegravir and rilpivirine as a two-drug regimen for HIV maintenance therapy is investigational and not approved anywhere in the world.
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single tablet in order to expand the treatment options available to people living with HIV.
About the SWORD Phase III Program for dolutegravir (Tivicay®) and rilpivirine (EDURANT®)
The Phase III program evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four drug regimen. In the clinical trials, dolutegravir and rilpivirine are provided as individual tablets. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy.
The primary endpoint is proportion of patients with plasma HIV-1 RNA < 50 copies per milliliter (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch, and adherence to treatment regimens.
About Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Sciences Ireland UC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
SOURCE: Janssen
Post Views: 97
– Two-drug regimen could offer many patients the option to switch to a regimen that does not include a nucleotide reverse transcriptase inhibitor –
CORK, Ireland I June 1, 2017 I Janssen Sciences Ireland UC, today announced that ViiV Healthcare has made regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). If approved, this will be the first two-drug regimen for the maintenance treatment of HIV-1 infection and will offer those living with HIV who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI).
The submissions are based on the Phase III SWORD studies which included more than one thousand patients who previously achieved viral suppression on a three or four drug antiretroviral regimen. The data were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in February.
A Priority Review voucher was submitted to the FDA along with the dolutegravir and rilpivirine two-drug regimen New Drug Application (NDA). Under the Prescription Drug User Fee Act, the anticipated target action date is six months after receipt of the application by the FDA.
“People living with HIV have always faced complex treatment regimens and a high pill burden. We know adherence is critically important for treatment outcomes and these regulatory submissions for dolutegravir plus rilpivirine represent a significant step forward in our efforts to deliver the first single-tablet, two-drug regimen for people living with HIV,” said Lawrence M. Blatt, Global Therapeutic Area Head, Infectious Disease Therapeutics, Janssen. “If approved, this novel regimen will offer patients who are virally suppressed a safe and effective treatment option.”
Janssen have brought medicines to market across a range of patient populations that have helped to transform the efficacy and tolerability of treatment. In the US, approximately one in three people are managing their HIV with a treatment regimen containing a Janssen medicine.
Use of dolutegravir and rilpivirine as a two-drug regimen for HIV maintenance therapy is investigational and not approved anywhere in the world.
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single tablet in order to expand the treatment options available to people living with HIV.
About the SWORD Phase III Program for dolutegravir (Tivicay®) and rilpivirine (EDURANT®)
The Phase III program evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four drug regimen. In the clinical trials, dolutegravir and rilpivirine are provided as individual tablets. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy.
The primary endpoint is proportion of patients with plasma HIV-1 RNA < 50 copies per milliliter (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch, and adherence to treatment regimens.
About Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Sciences Ireland UC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
SOURCE: Janssen
Post Views: 97
