GSK's ViiV submits transatlantic HIV drug applications

GlaxoSmithKline and its global specialist HIV company ViiV Healthcare, which it owns with Pfizer and Shionogi as shareholders, announced regulatory submissions to the European Medicines Agency and the US Food and Drug Administration on Friday, for a single-tablet, two-drug regimen of dolutegravir and rilpivirine, for the maintenance treatment of HIV-1 infection.

The FTSE 100 firm said the submissions were based on the SWORD studies that included more than 1,000 patients who previously achieved viral suppression on a three- or four-drug (integrase inhibitor, non-nucleoside reverse transcriptase inhibitor, or protease inhibitor-based) antiretroviral regimen.

GSK said the results of those studies were presented at the 2017 Conference on Retroviruses and Opportunistic Infections in February.

A recently-acquired priority review voucher was submitted to the FDA along with the dolutegravir and rilpivirine 2-drug regimen New Drug Application (NDA), the board explained.

Under the Prescription Drug User Fee Act, the anticipated target action date was six months after receipt of the application by the FDA.

The $130m cost of the voucher will be reported as a research and development expense in GSK's Q2 2017 adjusted results.

GlaxoSmithKline said tse of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy was “investigational”, and not approved anywhere in the world.

“As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment,” said ViiV CEO Deborah Waterhouse.

“At ViiV Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection, we are challenging the traditional HIV treatment paradigm to develop new treatment regimens.

“We look forward to working with regulatory authorities to bring this new single tablet, two-drug regimen to appropriate people living with HIV.”

John Pottage Jr, chief scientific and medical officer at ViiV Healthcare, said that traditionally, patients used a regimen of three or more drugs to maintain HIV viral suppression, but to best serve people living with HIV the company felt it “must always question” the status quo.

“We believed that dolutegravir would have the right profile to be a core agent in a two-drug regimen.

“Data from the SWORD studies supported our hypothesis that a two-drug regimen of dolutegravir and rilpivirine could maintain viral suppression and these regulatory submissions mark what may be a step change in HIV treatment,” Pottage said.

“We are grateful to the study participants and clinicians who have contributed so much to making these submissions possible.”