J&J's Darunavir-Based Single-Tablet HIV Regimen Gets FDA Nod
Johnson and Johnson JNJ announced that the FDA has approved Symtuza, a darunavir-based once-daily single-tablet regimen, for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed adults. Each film-coated tablet of Symtuza contains 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide.
The U.S. Department of Health and Human Services guidelines recommend darunavir-based therapies for treatment-naïve HIV patients in certain clinical situations.
The approval was based on data from two pivotal phase III studies, AMBER and EMERALD. The AMBER study evaluated the safety and efficacy of Symtuza versus a control regimen in adults with no prior antiretroviral (ARV) history. The EMERALD study evaluated the safety and efficacy of Symtuza in virologically suppressed adults.
Both studies showed that Symtuza was effective and well-tolerated, with up to 95% of patients achieving or maintaining virologic suppression. However, as part of its license from the FDA, the drug will have to carry a boxed warning about its risk of post-treatment acute exacerbation of hepatitis B.
Symtuza is also approved in Europe and Canada. The company plans additional regulatory filings in other markets worldwide. The company plans to present additional data on Symtuza, including data from an ongoing phase III rapid initiation study (DIAMOND) at AIDS 2018, in late July.
So far this year, Johnson & Johnson’s share price has decreased 7.6%, comparing unfavorably with the industry’s decline of 0.6%.
The latest entrant in J&J’s HIV portfolio is Juluca, for which J&J along with its partner GlaxoSmithkline GSK received the FDA approval, in November last year. Juluca is the first two-drug regimen that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen.
Juluca combines two approved HIV drugs — Tivicay (50 mg) and Edurant (25 mg) — into a single, once-daily pill for the treatment of virologically suppressed HIV-1 infection. The drug generated sales of £10 million in the first quarter of 2018. The drug also received approval in Europe, in May 2018.
Gilead GILD also gained the FDA approval for a single tablet HIV regimen (triple therapy) named Biktarvy, in February 2018, while a regulatory application is under review in the EU.
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Zacks Rank & Stock to Consider
J&J has a Zacks Rank #3 (Hold).
Another better-ranked stock from the same space is Illumina Inc. ILMN, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earnings per share estimates have increased from $4.83 to $4.87 for 2018 and from $5.57 to $5.61 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 23.17%. The stock has rallied 39.8% so far this year.
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