ViiV healthcare has submitted regulatory applications for the first HIV maintenance regimen comprised of only two medicines.
The submissions are based on studies that included more than one thousand patients who previously achieved viral suppression on a three- or four-drug antiretroviral regimen.
A recently acquired priority review voucher was submitted to the FDA along with the dolutegravir and rilpivirine 2-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. The $130 million cost of the voucher will be reported as an R&D expense in GSK’s Q2 2017 Adjusted results.
Use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy is investigational and not approved anywhere in the world.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, said: “Traditionally, we have used a regimen of three or more drugs to maintain HIV viral suppression, but to best serve people living with HIV we 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.”
ViiV Healthcare is a HIV specialist company majority-owned by GSK, with Pfizer and Shionogi as shareholders.