June 2, 2017 / 6:16 AM / in 2 months

BRIEF-GSK says ViiV Healthcare submits 2-drug HIV regimen application to EMA,U.S. FDA

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June 2 (Reuters) - Glaxosmithkline Plc:

* ViiV submits first 2-drug hiv regimen application

* ‍Priority review voucher submitted in US with anticipated target action date of 6 months​

* ‍EU and US submissions for single tablet combining dolutegravir and rilpivirine​

* ‍$130 million cost of voucher will be reported as an research and development expense in GSK's q2 2017 adjusted results​

* Under prescription drug user fee act, anticipated target action date is six months after receipt of application by FDA

* Use of dolutegravir and rilpivirine as a two-drug regimen for hiv-1 maintenance therapy is investigational and not approved anywhere in world Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +91 80 6749 1136)

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