The US Food and Drug Administration (FDA) has approved Juluca, the HIV treatment that is produced by ViiV Healthcare, the company that is co-owned by GlaxoSmithKline, Pfizer and Shionogi.
This was announced by GlaxoSmithKline on Wednesday. GlaxoSmithKline is the majority stakeholder in ViiV Healthcare.
For patients who have no previous report of treatment failure and who have reported no known substitutions associated with resistance to the individual components of Juluca are te htargte patients of Juluca. The treatment is meant to be used as a complete regimen for the purpose of maintenance of treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months.
Rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor and dolutegravir 50mg, an integrase strand transfer inhibitor makes up Juluca and is the first 2-drug regimen, the company said.
“The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care,” said ViiV CEO Deborah Waterhouse.
“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive lifelong treatment for their chronic condition.”
When tested on patients, the treatment achieved non-inferior viral suppression at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies where SWORD-12 and SWORD-2,2 were the two pivotal phase III clinical trials, the data from which formed the basis for the this FDA approval, the company said.
Between treatment arms, the virologic suppression rates were similar.
While occurring more frequently in the investigational arm, in both arms of the study, there was low occurrence of drug related adverse events and adverse events leading to withdrawal.
“Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir,” said ViiV’s chief scientific and medical officer John C Pottage.
“Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”
The reduction of the lifetime burden of treatment for people living with HIV is the aim of the drug Juluca which is also the first medicine in ViiV’s 2-drug regimen pipeline.
In addition to cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients, a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, are the two drugs that re undergoing research and development to ascertain the potential of the two drugs the company further said.
(Source:www.digitallook.com
This was announced by GlaxoSmithKline on Wednesday. GlaxoSmithKline is the majority stakeholder in ViiV Healthcare.
For patients who have no previous report of treatment failure and who have reported no known substitutions associated with resistance to the individual components of Juluca are te htargte patients of Juluca. The treatment is meant to be used as a complete regimen for the purpose of maintenance of treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months.
Rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor and dolutegravir 50mg, an integrase strand transfer inhibitor makes up Juluca and is the first 2-drug regimen, the company said.
“The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care,” said ViiV CEO Deborah Waterhouse.
“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive lifelong treatment for their chronic condition.”
When tested on patients, the treatment achieved non-inferior viral suppression at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies where SWORD-12 and SWORD-2,2 were the two pivotal phase III clinical trials, the data from which formed the basis for the this FDA approval, the company said.
Between treatment arms, the virologic suppression rates were similar.
While occurring more frequently in the investigational arm, in both arms of the study, there was low occurrence of drug related adverse events and adverse events leading to withdrawal.
“Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir,” said ViiV’s chief scientific and medical officer John C Pottage.
“Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”
The reduction of the lifetime burden of treatment for people living with HIV is the aim of the drug Juluca which is also the first medicine in ViiV’s 2-drug regimen pipeline.
In addition to cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients, a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, are the two drugs that re undergoing research and development to ascertain the potential of the two drugs the company further said.
(Source:www.digitallook.com
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