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Glaxo (GSK) Eyes Nod for Triumeq Expanded Use in Pediatric HIV

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GlaxoSmithKline’s GSK HIV subsidiary, ViiV Healthcare announced that a regulatory application has been filed with the FDA to seek approval for expanded use of its HIV drug Triumeq in younger children with HIV.

Glaxo’s regulatory submission seeks approval for a new dispersible tablet formulation of Triumeq, which is a fixed-dose combination of abacavir, dolutegravir and lamivudine, for children with HIV. In addition, the company is also seeking approval for expanding the use of Triumeq for pediatric patients weighing 14 kgs and above. At present, Triumeq is approved for treating HIV-1 infection in pediatric patients weighing at least 40 kg apart from being approved for use in adults.

So far this year, Glaxo’s shares have risen 4.3% compared with the industry’s 8% increase.

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Glaxo’s dolutegravir franchise comprises two three-drug regimens — Triumeq and Tivicay — and two two-drug regimens — Juluca and Dovato. Juluca is a combination of dolutegravir and J&J’s JNJ Edurant (rilpivirine) while Dovato is a single-tablet regimen of Tivicay (dolutegravir) + lamivudine. Sales of dolutegravir franchise were up 14% at constant exchange rate (CER) in the second quarter of 2021 as strong growth in sales of Dovato, Juluca and Tivicay was partially offset by the decline in sales of Triumeq.

ViiV Healthcare is majorly owned by Glaxo with Pfizer PFE and Shionogi Limited has a stake in the company. ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables), and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies).

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

A better-ranked large drugmaker is Sanofi SNY, which has a Zacks Rank of 2 (Buy). Its earnings estimate for 2022 has gone up from $4.30 to $4.31 over the past 60 days.


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