Gilead Submits Supplemental NDA for Descovy for HIV Pre-Exposure Prophylaxis
April 05 2019 - 9:28AM
Dow Jones News
By Michael Dabaie
Gilead Sciences Inc. (GILD) said Friday it submitted a
supplemental New Drug Application to the U.S. Food and Drug
Administration for Descovy for pre-exposure prophylaxis to reduce
the risk of sexually acquired HIV-1 infection among individuals who
are HIV-negative and at risk for HIV.
A Priority Review voucher was submitted with the filing, leading
to an anticipated review time of six months, Gilead said.
The filing is supported by data demonstrating non-inferiority
compared to Truvada coupled with bone and renal safety advantages
in people at risk of sexually acquired HIV infection, Gilead
said.
Shares were up 0.5% to $67.19 premarket.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
April 05, 2019 09:13 ET (13:13 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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