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# Viiv Healthcare Gets ‘Complete Response’ on HIV NDA
- URL: https://www.fdaweb.com/viiv-healthcare-gets-complete-response-on-hiv-nda/
- Published: 2020-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:57:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145765

FDA has issued ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treating HIV-1 infection in virologically suppressed adults. The letter cited chemistry manufacturing and controls (CMC) concerns as the reason for not approving the submission, the company says. “There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date,” it says. ViiV expects to meet with FDA soon to determine the next steps for the NDA.

Viiv describes cabotegravir as an integrase strand transfer inhibitor developed by the company and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland. The combination regimen is not approved anywhere in the world, it adds.