GlaxoSmithKline's ViiV gets FDA approval for HIV treatment

GlaxoSmithKline said on Wednesday that ViiV Healthcare, the global specialist HIV company it majority owns, with Pfizer and Shionogi as shareholders, has announced that the US Food and Drug Administration (FDA) has approved Juluca,

The FTSE 100 firm said Juluca was indicated as a complete regimen for the maintenance treatment of HIV-1 infection, in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

It said Juluca is the first 2-drug regimen comprising dolutegravir 50mg, an integrase strand transfer inhibitor and rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor.

“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.”

This FDA approval was primarily based on data from two pivotal phase III clinical trials, SWORD-12 and SWORD-2,2 which showed the 2-drug regimen 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.

Virologic suppression rates were similar between treatment arms.

Drug related adverse events and adverse events leading to withdrawal occurred in low frequencies in both arms of the study, but more frequently in the investigational arm.

“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.”

Juluca is the first medicine in ViiV’s 2-drug regimen pipeline, which was looking to help lessen the lifetime burden of treatment for people living with HIV.

It said its research and development efforts were exploring the potential of two further 2-drug regimens both in phase III development - a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, as well as cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients.