GSK: submits HIV two-drug regimen for FDA approval
(CercleFinance.com) - GlaxoSmithKline has submitted a two-drug regimen for the treatment of HIV for approval with U.
S. health regulators, the British drugmaker said on Monday.
Its specialist HIV unit ViiV Healthcare today submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, combination of ViiV's cabotegravir and Janssen's rilpivirine to treat HIV-1 infection.
This targets patients whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
ViiV and Janssen plan to submit regulatory applications for the two-drug regimen to the European Medicines Agency, Health Canada and other global agencies in the coming months.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
S. health regulators, the British drugmaker said on Monday.
Its specialist HIV unit ViiV Healthcare today submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, combination of ViiV's cabotegravir and Janssen's rilpivirine to treat HIV-1 infection.
This targets patients whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
ViiV and Janssen plan to submit regulatory applications for the two-drug regimen to the European Medicines Agency, Health Canada and other global agencies in the coming months.
Copyright (c) 2019 CercleFinance.com. All rights reserved.