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Glaxo and J&J's Two-Drug HIV Regimen Juluca Gets EU Approval

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GlaxoSmithKline plc GSK and partner J&J JNJ announced that the European Commission (EC) has granted marketing approval to Juluca, making it Europe’s first two-drug HIV treatment. 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

Juluca gained approval in the United States in November last year and generated sales £10 million in the first quarter of 2018.

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 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.

The approval in the EU was expected as in March this year the Committee for Human Use of Medicinal Products (CHMP) of the European Medicines Agency (EMA) had given a positive opinion recommending approval of Juluca.

This year so far, J&J’s shares have declined 11.4% while that of Glaxo have gone up 13%. In the said time frame, the industry has witnessed a decline of 3.7%.

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.

Juluca’s approval was based on data from two phase III SWORD studies. Data from these studies showed that the combination of Tivicay and Edurant 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.

We remind investors that Gilead GILD also gained FDA approval for a single tablet HIV regimen (triple therapy) this year.  Biktarvy gained FDA approval in February this year while a regulatory application is under review in the EU. The STR is a fixed-dose combination of three drugs bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF).

Both Glaxo and J&J carry 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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