Johnson & Johnson said on Tuesday its HIV drug collaboration, Cabenuva, has received further approvals in the US.
The New Jersey, US-based pharmaceutical company’s Janssen Pharmaceutical arm said the US Food & Drug Administration has approved Cabenuva to treat HIV-1 in virologically suppressed adolescents.
The expanded indication follows positive data from week 16 interim analysis of ongoing studies of Canenuva for children and adolescents.
Cabenuva was co-developed as part of a collaboration between Janssen Pharmaceuticals and North Carolina-based pharmaceutical joint venture ViiV Healthcare Ltd, which is majority-owned by GlaxoSmithKline PLC, with Pfizer Inc and Shionogi & Co as minority shareholders.
It is a regimen of Janssen’s rilpivirine drug and Viiv Healthcare’s cabotegravir.
Earlier this month, Cabenuva received FDA approval for a label update, allowing the drug to be initiated with or without an oral lead-in period. In February, the FDA permitted a label update for it to be used in doses every two-months, in addition to the monthly dose permitted before.
‘We’re proud of our longstanding efforts to address the needs of young people living with HIV. By advancing new treatment options to meet the unique needs of adolescents living with HIV, we can help build a future where young people are not defined or limited by their diagnosis,’ said Candice Long, president of Infectious Diseases & Vaccines at Janssen Therapeutics.
J&J shares closed down 0.1% at $177.74 each in New York on Tuesday, with Pfizer down 1.0% to $52.74 each.
GSK shares were up 0.1% at 1,643.20 pence each in London on Wednesday morning.
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