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J&J & Glaxo Get FDA Approval for First Two-Drug HIV Regimen

Zacks Equity Research

Johnson & Johnson JNJ and partner GlaxoSmithKline GSK announced FDA approval for Juluca, a two-drug complete regimen of Tivicay/rilpivirine and Edurant/dolutegravir as a single tablet for the treatment of HIV-1 infection.

Tivicay, a novel investigational integrase strand transfer inhibitor (INSTI), is marketed by ViiV Healthcare, an HIV company majorly owned by Glaxo and Pfizer PFE. Edurant, on the other hand, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen, J&J’s pharma arm. Juluca has been developed under a partnership between ViiV Healthcare and Janssen.

This year so far, J&J’s share price is up 20.1%. This compares favorably with 14.1% increase witnessed by the industry.

Coming back to the latest news, Juluca’s approval was based on data from two phase III SWORD studies. Data from these studies published in February this year showed that the combination of dolutegravir/rilpivirine antiretroviral was as effective as a three- or four-drug antiretroviral regimen as a maintenance therapy in HIV patients who have already achieved viral suppression.

Juluca, the first two-drug regimen to be approved, reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen.

We remind investors that Gilead’s GILD bictegravir single table regimen (STR) for HIV treatment is under priority review in the United States. The FDA is expected to announce its decision in February next year. The STR is a fixed-dose combination of bictegravir, an INSTI, and emtricitabine/tenofovir alafenamide (FTC/TAF), a dual-NRTI backbone. The combination is under review in the EU as well. Gilead’s HIV franchise is a major contributor to sales with approved drugs like Genvoya, Truvada, Atripla, Stribild, Descovy, Odefsey and Complera.

J&J 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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