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Glaxo's Dovato Gets FDA Nod for Treatment-Naive HIV Patients

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GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare announced that the FDA has granted approval to a new once-daily, single-tablet two-drug regimen (2DR), Dovato for the treatment of newly-diagnosed adults with HIV-1 infection.

Dovato is a fixed-dose combination of Glaxo’s successful HIV drug Tivicay(dolutegravir- 50 mg) in combination with lamivudine (300 mg). The submission is based on the global GEMINI 1 & 2 studies that evaluated the two-drug regimen in treatment naïve HIV patients who have not received prior antiviral therapy compared to a three-drug regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine. The new drug application (NDA) for this single-tablet regimen was filed in October last year  using a priority review voucher.

At week 48, the studies demonstrated that the dolutegravir and lamivudine regimen was non-inferior to the standard three-drug regimen. This means a two-drug HIV regimen can control HIV in treatment naïve patients as effectively as a three-drug regimen, thereby exposing these newly diagnosed patients to fewer drugs at the start of treatment.  A similar application is under review in the EU.

ViiV Healthcare is an HIV company majorly owned by Glaxo and Pfizer PFE. It markets another two-drug, once-daily, single pill for HIV, Juluca, which is a combination of Tivicay and J&J’s JNJ Edurant (rilpivirine). Juluca was approved in the United States in late 2017 and in the EU in mid-2018 for HIV patients that have received prior treatment.

So far this year, Glaxo’s shares have outperformed the industry, rising 9.1% compared with 3.6% increase for the industry.



HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, Tivicay, Triumeq and Juluca in its portfolio. HIV sales totaled £4.7 billion in 2018 with dolutegravir-based regimens generating £4.4 billion driven by increased market share.

ViiV Healthcare is focused on advancing HIV care by exploring new treatment paradigms (two-drug regimens), new modalities (long-acting injectables) and new mechanisms of actions (including maturation inhibitors and broadly neutralising antibodies). Key candidates in late-stage development include a long-acting, injectable two-drug regimen of cabotegravir and rilpivirine and fostemsavir in heavily pre-treated HIVpatients. New drug applications for both these candidates are expected to be filed this year.

Other key players in the HIV market are Gilead GILD, Merck, AbbVie and J&J.

Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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