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FDA CRL Delays ViiV’s Long-Acting Cabotegravir Regimen

Manufacturing Questions Triggered FDA Complete Response Letter

 
• By Sten Stovall

ViiV Healthcare will not be able to launch its cabotegravir and rilpivirine long-acting HIV treatment in January after receiving an FDA Complete Response Letter.

Delay
Complete Response Letter Delays ViiV’s Planned 2DR Launch • Source: Shutterstock

The unexpected arrival of a complete response letter from the US Food And Drug Administration (FDA) means ViiV Healthcare will not be able to launch its long-acting double drug HIV-1 treatment next month, as it had confidently planned.

ViiV’s head of R&D Kimberly Smith had told Scrip in an interview earlier in December that FDA approval of the combination was expected “imminently” and that the company was getting its

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