BioCentury
ARTICLE | Clinical News

ViiV seeks FDA approval for two-drug HIV-1 regimen

October 26, 2018 6:50 PM UTC

ViiV Healthcare Ltd. (Brentford, U.K.) said it submitted an NDA to FDA for its single-tablet, two-drug regimen of dolutegravir and lamivudine to treat HIV-1 infection. The company used a Priority Review voucher to speed up the review.

A ViiV spokesperson told BioCentury the company used the tropical disease Priority Review voucher that GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received this year when FDA approved malaria drug Krintafel tafenoquine...

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ViiV Healthcare Ltd.