Glaxo's Dovato Gets FDA Nod for Treatment-Naive HIV Patients
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.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.
This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
See their latest picks free >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Pfizer Inc. (PFE) : Free Stock Analysis Report
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
