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J&J (JNJ) Gets FDA Nod for HIV Jab, Cabenuva, in Adolescents

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Johnson & Johnson (JNJ - Free Report) announced that the FDA has approved its long-acting injectable HIV regimen, Cabenuva, for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter) aged 12 years and above.

Cabenuva is a combination of ViiV Healthcare’s long-acting injectable, cabotegravir and J&J’s injectable, rilpivirine.

ViiV Healthcare, a company focused on HIV, is majorly owned by Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) . After Pfizer and Glaxo established it in 2009, Japan’s Shionogi joined as a shareholder in October 2012.

Following the latest FDA nod, Cabenuva became the first and only complete long-acting regimen approved for treating HIV-1 infection in adolescents. The drug is approved for adolescents weighing at least 35 kg who are on a stable antiretroviral regimen, have no history of treatment failure and no resistance to either cabotegravir or rilpivirine.

The approval of the two-month dosing regimen for adolescents will reduce dosing to as few as six times a year.

The label expansion nod is supported by studies in adults and data from the week 16 interim analysis of the ongoing MOCHA study.

Shares of Johnson & Johnson have rallied 3.9% so far this year compared with the industry’s increase of 3%.

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Cabenuva was approved by the FDA as a once-monthly treatment for HIV-1 in virologically suppressed adults in January 2021. In February 2022, the FDA granted approval to the two-month dosing regimen of Cabenuva for virologically suppressed adults living with HIV without prior treatment failure, or resistance to cabotegravir or rilpivirine.

Cabenuva is also approved in the EU, Canada and several other countries.

GSK and PFE’s ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms, and delivering effective and innovative medicines for the prevention and treatment of HIV.

Zacks Rank & Key Pick

Johnson & Johnson currently carries a Zacks Rank of #3 (Hold). A top-ranked stock in the drug/biotech sector is Innoviva, Inc. (INVA - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Innoviva’s earnings estimates have been revised 20.5% upward for 2022 and 27.9% upward for 2023 over the past 60 days. The INVA stock has rallied 14.1% year to date.

Earnings of Innoviva surpassed estimates in each of the trailing four quarters. INVA has an average earnings surprise of 2,213.45%.


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