Once-monthly HIV regimen gets first regulatory approval

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/spukkato)
(Image: Getty/spukkato)

Related tags: Hiv, ViiV Healthcare

Health Canada marked the first positive nod to ViiV for its once-monthly HIV regimen, following rejection by the US FDA.

ViiV Healthcare, a HIV treatment developer, is majority owned by GSK, with Pfizer and Shionogi as shareholders.

The HIV treatment, Cabenuva (cabotegravir and rilpivirine), will be marketed as a kit with two injectable suspensions, after it was approved by Health Canada as the first and only once-monthly regimen to replace antiretrovirals in virologically stable and suppressed patients.

Concurrently, the Canadian regulator provided approval for Vocabria (cabotegravir) oral tablets, which are indicated to be administered for short time periods in conjunction with Cabenuva.

The long-acting, once-monthly required administration of Cabenuva, which ViiV developed collaboratively with Janssen, is expected to improve convenience for patients with HIV.

When administered to HIV patients participating in Phase III clinical studies, Cabenuva was shown as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression.

An application for approval of Cabenuva filed with the US Food and Drug Administration (FDA) was rejected at the beginning of the year​, with the regulator citing issues regarding chemistry, manufacturing and controls (CMC).

ViiV stated that it is working on the preparation of a new application, while it also expects review decisions by the European Medicines Agency (EMA) and regulatory authorities in Switzerland and Australia.

Related topics: Markets & Regulations, Regulations

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