Gilead Submits New Drug Application to FDA for HIV Treatment

Gilead recently submitted a new drug application to FDA seeking approval for its investigational, long-acting HIV-1 inhibitor, lenacapavir, for HIV treatment.

The submission is supported by data from the Phase 2/3 CAPELLA trial evaluating the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen.

In the study, a significantly higher proportion of participants who received lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 copies/milliliters from baseline compared with those receiving placebo, at 88 percent versus 17 percent, respectively. 

Overall, lenacapavir was generally well-tolerated with no serious adverse events reported. Additional key data from the trial is expected in July 2021.

“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multi-drug resistant HIV who have very limited treatment options,” Merdad Parsey, MD, PhD, chief medical officer at Gilead, said in the announcement.

“The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV,” Parsey continued. 

Lenacapavir is a potential first-in-class capsid inhibitor for the treatment of HIV infection without overlapping resistance with any currently approved antiretroviral therapy (ART). 

In May 2019, FDA granted Breakthrough Therapy Designation for the development of lenacapavir to treat HIV infection in heavily-treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. 

The agency based its decision on the impact of treatment with lenacapavir on reducing brain amyloid beta (Aβ) and clinical decline. Overall, researchers found a consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.

Currently, the drug is being studied as an every-six-month subcutaneous injection.

Additionally, lenacapavir is being developed in combination with other antiretroviral agents for HIV treatment in adults and pediatric patients who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance, or safety considerations.

Gilead stated that it plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

There are currently no approved treatments for HIV or AIDS. But recently, FDA approved ViiV Healthcare’s Cabenuva, the first and only complete long-acting injectable HIV treatment for positive adults. 

The drug will be administered once a month and will replace the current treatment regimen in those who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.