GlaxoSmithKline plc (LON:GSK) and ViiV Healthcare have made regulatory submissions to both the European Medicines Agency and the US Food and Drug Administration for use of a single-tablet, two-drug regimen for the maintenance treatment of HIV-1 infection.
The submission is for a combination of dolutegravir, developed by ViiV Healthcare and Tivicay, and rilpivirine, developed by Edurant, and Janssen Sciences Ireland UC.
ViiV Healthcare, the global specialist HIV company, is majority-owned by Glaxo, with US firm Pfizer Inc. (NYSE:PFE) and Japan’s Shionogi Limited as shareholders.
READ: GSK announces positive study results for HIV treatment
Glaxo said the submissions are based on the SWORD studies that included more than one thousand patients who previously achieved viral suppression on a three- or four-drug antiretroviral regimen.
John C Pottage, Jr, MD, chief scientific and medical officer of ViiV Healthcare, said: “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.”
Priority review voucher submitted to the FDA
In its statement, Glaxo said that a recently acquired priority review voucher was submitted to the FDA along with the New Drug Application, with the anticipated target action date set at six months after receipt of the application.
The FTSE 100-listed firm added that the US$13mln cost of the voucher will be reported as an R&D expense in its Q2 2017 adjusted results.
Deborah Waterhouse, CEO of ViiV Healthcare said: "As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment.”
She added: “We look forward to working with regulatory authorities to bring this new single tablet, two-drug regimen to appropriate people living with HIV."
In a note to clients, analtysts at Shore Capital said: “It is hoped that the use of two-drug regimens could offer improved safety and tolerability (in comparison to three- or four-drug regimens) given the chronic exposure of HIV-1 patients to antiretroviral therapy.”
In early morning trading, Glaxo shares were 0.7%, or 12p higher at 1,715.50p.
-- Adds analyst comment, share price --