Chipping away at Gilead’s HIV empire, GSK’s ViiV submits NDA for 2-drug HIV regimen — playing voucher card for speedy FDA review

GSK’s ambition to capture a bigger piece of the HIV drug market from US rival Gilead continues as its majority-owned ViiV Healthcare submitted an application to market it’s two-drug  treatment comprising dolutegravir (DTG) and lamivudine (3TC) to the FDA in tandem with a priority review voucher (PRV), empowering the company to receive a response from the US regulator in a faster-than-standard six months.

ViiV was established in 2009 by the British drugmaker in partnership with Pfizer $PFE, with Shionogi joining as a shareholder in 2012. The company’s current portfolio of 13 antiretroviral HIV therapies generated £4.35 billion last year. On Friday a spokesperson from the Middlesex, UK-based company said it had procured the PRV from GSK which was granted the tropical disease PRV after securing approval for its malaria drug Krintafel earlier this year.

GSK’s {GSK} approach to grabbing market share from Gilead $GILD  — which currently dominates the HIV market that is estimated to hit $22.5 billion by 2025 — is to convince regulators, doctors and patients to adopt its two-drug regimens, versus Gilead’s triple-drug cocktails, that could potentially result in fewer toxic side-effects, reduce dosing frequency, and be more cost-effective. Some physicians — and Gilead — take the view that this may not be the most effective strategy because the virus will only have to fight against two drugs which could culminate in drug resistance.

Results of two phase III GEMINI trials testing the two-drug regimen of DTG and 3TC presented earlier this year showed that ViiV’s therapy worked as well as standard three-drug therapy in treatment-naive patients with both low and high levels of the virus, and significantly, no patient in the 1,400 patients enrolled across the trials, developed drug resistance. This was a crucial worry as there was a reported case of drug resistance in a previous study.

If approved, this DTG and 3TC regimen is also poised to be cheaper as 3TC is no longer patent protected. Meanwhile, the DTG portion of the regimen is under regulatory investigation after data from patients in Botswana suggested a link between the drug and birth defects.

ViiV, whose other two-drug regimen Juluca that includes DTG won FDA approval last year, has already submitted an application to the single-tablet DTG and 3TG regimen with European regulators in September.

Image: HIV Shutterstock

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