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.

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