The NDA was based on positive Phase III data that shows the once-a-month treatment is as effective as the daily standard of care.
HIV-focused ViiV Healthcare submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for potential approval of its investigational combination treatment for HIV-1. Submission of the NDA comes less than a month after ViiV snagged regulatory approval of Dovato.
ViiV, a subsidiary of GlaxoSmithKline, is aiming for approval of its monthly injectable combination of ViiV’s cabotegravir and Janssen’s rilpivirine (Edurant) as a treatment of HIV-1 in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. The company is seeking approval based on results from two trials, the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) Phase III studies. The two studies included more than 1,100 patients and the results demonstrated that the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.
“Our focus on developing innovative new HIV treatments, including long-acting injectable therapies, supports our goal of giving people living with HIV more options for managing the virus. The ATLAS and FLAIR data support the efficacy and safety of this investigational two-drug regimen, and the fact that more than 85 percent of study participants said they preferred it to their prior, daily oral therapy suggests we are delivering a welcome option. If approved, people receiving the monthly injectable regimen of cabotegravir and rilpivirine will reduce the number of days they have to take treatment from 365 to 12 per year,” John Pottage, chief scientific and medical officer of ViiV Healthcare said in a statement.
Deborah Waterhouse, ViiV’s chief executive officer, said the once-per-month injectable treatment has the potential to improve quality of life of HIV patients due, in part, to the dosing regimen. Waterhouse said the once-per-month dose provides a medication with the same level of safety and efficacy as today’s standard of care, an oral three-drug regimen that has to be taken every day.
“ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option,” Waterhouse said in a statement.
In addition to seeking potential approval in the U.S., ViiV said it, along with Janssen, plans to submit regulatory applications for the two-drug regimen of cabotegravir and rilpivirine to the European Medicines Agency, Health Canada and other global agencies in the coming months. As part of the regulatory submission package to the FDA, ViiV submitted a second NDA for an oral tablet formulation of cabotegravir that would be taken as an oral lead-in with an already-approved, once-daily, oral tablet formulation of rilpivirine, the company said.
