ViiV Healthcare announced that it has received a complete response letter (CRL) from the FDA, rejecting its marketing application for its long-acting, monthly injectable therapy for HIV.
The combination treatment was touted by ViiV as a next-generation HIV therapy, due to the fact that it could free people with the virus from taking daily oral pills.
The monthly injection is a combination of ViiV’s integrase inhibitor cabotegravir and Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.
ViiV – which is majority owned by GlaxoSmithKline – said that it “will work closely with the FDA to determine the appropriate next steps for this new drug application”.
In the CRL, the FDA cited concerns regarding the treatment’s chemistry manufacturing and controls process, but there was no issues surrounding the safety of the product.
This is a blow to ViiV, which has been vying for market share from Gilead. Both companies make billions of dollars each year from selling daily oral drugs for HIV, so this monthly injectable could have made a significant dent in Gilead’s sales.
In previous trials testing the long-acting treatment, ViiV’s injectable was as effective as a standard three-drug oral regime at suppressing levels of HIV. Two trials, named ATLAS and FLAIR, formed the basis of the regulatory filings for the regimen.
ATLAS involved pateints who had been previously treated with long-acting antiretroviral therapy (ART), and showed that the combination injection matched standard therapy on viral suppression rates. Three patients treated with ViiV’s injectable (1%) demonstrated a failure to suppress HIV, while there were four cases on the oral therapy.
FLAIR recruited newly-diagnosed patients and along with data showing non-inferiority to oral treatment, revealed a similar 1% rate of treatment failure, caused by the emergence of treatment resistance strains.
ViiV’s rival Gilead was the first company to bring a single-tablet triple therapy – Biktarvy – to market, and the former has been desperately pushing its own two-drug oral therapies through the pipeline to try and claim more market share.
Gilead’s Biktarvy has grown quickly since its launch last year, and will most likely hit a $1bn-plus annual sales rate.
According to GlobalData, the overall value of the HIV market is not expected to change dramatically in upcoming years, but there will be a predicted shift towards increased use of simpler, single-tablet regimens as the big-selling products change.