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Glaxo (GSK) HIV Drug Tivicay Gets FDA Approval for Toddlers

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GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare, announced that the FDA has approved the oral suspension of its HIV drug, Tivicay (dolutegravir) tablets, in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients aged at least four weeks and weighing at least 3kg. The drug will be available under the tradename of Tivicay PD. The patient population includes treatment-naive or -experienced but integrase strand transfer inhibitor (INSTI)- naive patients.

Moreover, the FDA also approved a label expansion of Tivicay 50mg film-coated tablet to include pediatric HIV patients weighing 20kg and above.

Regulatory applications seeking approval for Tivicay PD and the extended indication of the Tivicay tablet in similar indications are under review in Europe.

Tivicay was until now approved in the United States as a treatment for HIV-1 in children from six years of age and weighing more than 30kg as well as adult patients.

Glaxo stated that HIV medication and treatments are often hard to swallow or tolerate. Its oral suspension formulation of Tivicay will make administration of the drug easier as the tablet can be dispersed in water.

The company stated that there are approximately 1.7 million children living with HIV across the globe, with the majority of AIDS-related deaths among children occuring during the first five years of life. Moreover, there is poor availability of optimized pediatric formulations of antiretrovirals for treating HIV in young children. An easy-to-administer formulation and poor availability of HIV drugs for young HIV patients may boost the demand for Tivicay going forward.

Meanwhile, ViiV Healthcare has a voluntary licensing policy under which it allows generic versions of dolutegravir to be manufactured and sold royalty-free in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, as well as some upper-middle-income countries. It also provides resources to expedite the development and introduction of optimized pediatric formulations of dolutegravir through partnership with Clinton Health Access Initiative and Unitaid. Under this partnership, two generic manufacturers hold pediatric dolutegravir sub-licences — Mylan Laboratories Limited and Macleods Pharmaceuticals Limited. Mylan has already submitted a new drug application seeking approval for a scored dolutegravir 10mg dispersible tablet for tentative approval under the FDA President’s Emergency Plan for AIDS Relief scheme. A similar regulatory submission is due from The Macleods.

So far this year, Glaxo’s shares have declined 14% compared with the industry’s 5% decline.


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. Dovato was launched in the United States and Europe in 2019. Sales of Glaxo’s HIV business rose 8% in the first quarter of 2020

Zacks Rank & Key Pick

Glaxo currently has a Zacks Rank #2 (Buy). Eli Lilly and Company (LLY - Free Report) is another top-ranked large cap pharma stock, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Lilly’s earnings estimates have moved up from $6.77 to $6.81 for 2020 and from $7.92 to $8.02 for 2021 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with the average being 8.24%. Its shares have risen 9.2% so far this year.

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