Long Lasting Injectables delayed after FDA denial
Pharmaceutical firms ViiV Healthcare and Janssen were dealt a blow when the Food & Drug Administration (FDA) in the United States turned down turned down approval for their long awaited Long-acting injectable treatment, Cabenuva.
Cabenuva is based on ViiV Healthcare’s integrase inhibitor (INI) Cabotegravir and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) Rilpivirine, and is racing to be the first non-daily dosing HIV treatment to market.
The rejection by the FDA comes from a lack of data provided in the ‘Chemistry manufacturing and controls (CMC)’ section of the application and doesn’t speak to the safety or efficacy of the treatment itself.
Data reported from the First Long-Acting Injectable Regimen (FLAIR) and Antiretroviral Therapy as Long Acting Suppression (ATLAS) studies have shown Cabenuva to be as effective as daily oral treatment with the majority of study participants preferring the injections to their previous oral treatments.
ViiV Healthcare have said that they are “work closely with the FDA to determine the appropriate next steps for this new drug application” and hope to have approval back on track soon, although they are unable to speculate the timeline at this point.
It seems that patients and clinicians hoping to get their hands on Long Acting Injectables in early 2020 might have to wait just that bit longer.
Check out our reporting on upcoming treatments from our November coverage from the EACS conference in Basel here: https://life4me.plus/en/news/treatment-5651/