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Glaxo's (GSK) Rukobia Gets EU Nod for Multidrug-Resistant HIV

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GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare announced that European Commission has granted approval to Rukobia (fostemsavir) in combination with other antiretroviral (ARV) therapies to treat heavily treatment-experienced adult patients with multidrug-resistant HIV.

The approval of Rukobia 600mg extended-release tablets was based on data from the pivotal phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia, a first-in-class attachment inhibitor, in combination with an optimized background therapy (“OBT”) in the given patient population. Data from the study showed that 60% of heavily treatment-experienced adult patients who received Rukobia with an OBT achieved and maintained viral suppression at 96 weeks of treatment. Rukobia was approved in the United States in July last year.

Rukobia’s EU approval is the second important regulatory approval in the HIV segment of Glaxo this year. Last month, the FDA approved Cabenuva, a long-acting injectable regimen of Glaxo’s cabotegravir and J&J’s (JNJ - Free Report) Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults. Cabenuva is also approved in Canada and EU. The long-acting regimen will reduce the frequency of treatment days from 365 to 12 per year, thereby removing the need to take daily oral pills. The FDA simultaneously approved Vocabria (cabotegravir oral tablets) for short-term HIV treatment in combination with rilpivirine tablets.

So far this year, Glaxo’s shares have declined 3.7% against the industry’s 1.1% increase.


Please note that Pfizer (PFE - Free Report) and Shionogi Limited own stakes in ViiV Healthcare.

HIV is a key therapeutic area for Glaxo with dolutegravir-based regimens in its portfolio. The dolutegravir franchise comprises two three-drug regimens, namely Triumeq and Tivicay and two two-drug regimens, Juluca and Dovato. While sales of the two-drug regimens are rising, Glaxo is seeing decline in sales of Triumeq and Tivicay due to the transition of patients from three-drug regimens to two-drug regimens.

Rising competitive pressure coupled with shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. Sales rose only 1% at constant exchange rate in 2020.

Other key players in the HIV market are Gilead Sciences (GILD - Free Report) ,Merck and AbbVie.

Glaxo currently has 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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