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.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.