VIiV Healthcare Gets FDA Priority Review For Two-Drug HIV Regimen

July 21, 2019
by John Kelly, MD
VIiV Healthcare Gets FDA Priority Review For Two-Drug HIV Regimen

ViiV Healthcare, the HIV subsidiary for GlaxoSmithKline, was recently given the Priority Review designation from the FDA for the development of a new drug application that involves an injectable two-drug HIV, long-acting regimen.

Glaxo filed an NDA in April with the goal of getting approval for a two-drug monthly regimen for its cabotegravir and the JNJ Edurant to treat HIV-1 infected individuals who have maintained their viral suppression and have not become resistant to either rilpivirine or cabotegravir.

The FDA granted the Priority Review in June, which means a decision should be expected around Dec. 29, 2019.

Viiv Healthcare recently said it would start a first-ever study to find and look at ways in which its once-a-month injectable HIV treatment could be used in the real world. The approach will be different and a step up from the controlled clinical study setting.

Glaxo has been working on HIV regimes as a therapeutic area for some time, - adding many successful dolutegravir-based regimes to its portfolio. ViiV Healthcare was granted FDA approval for Dovato - a single-table two-drug regimen to treat native HIV-1 adults. During the first quarter of 2019, HIV sales for dolutegravir-based regimens produced £1.07 million, bringing the total amount of sales to £1.12 billion.

The company agreed that its dolutegravir franchise was a bit slower than in previous quarters due to an increase in competitiveness on the market.

ViiV Healthcare is committed to improving HIV care by looking at various treatment paradigms, new action mechanisms and modalities. Glaxo, along with its two-drug regimen, is working on fostemsavir, which is geared toward the heavy pre-treatment HIV patients. Glaxo is expected to file for FDA approval for fostemsavir in the latter half of 2019.


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