Gilead Submits NDA for HIV Single Tablet Regimen

Gilead Sciences has submitted an NDA for a once-daily single tablet regimen to treat HIV-1 infection in adult and pediatric patients 12 years and older, using a priority review voucher that it acquired from Knight Pharmaceuticals for $125 million in November 2014.

Using the voucher reduces the FDA’s target review time from the standard 10 months to just six months.

The product, which combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide 25 mg with Janssen’s rilpivirine 25 mg, is intended for people who are HIV treatment-naive or whose virus is suppressed and want to replace their current antiretroviral treatment regimen.

If approved, Gilead would be responsible for the drug’s manufacturing, registration, distribution and commercialization in most countries, while Janssen would distribute it in roughly 17 markets.

Gilead plans to submit a regulatory application for the regimen in the EU in the third quarter of this year.

The NDA is Gilead’s third FDA filing in less than a year based on tenofovir alafenamide, which is an investigational nucleotide reverse transcriptase inhibitor with high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate).

Last November, the drugmaker filed an NDA for a once-daily single tablet HIV regimen combining the drug with elvitegravir, cobicistat and emtricitabine. That filing was followed by one in April for two doses of a fixed-dose combination of tenofovir alafenamide and emtricitabine for use in conjunction with other HIV antiretroviral drugs.

A fourth regimen is under development, Gilead says. — Jonathon Shacat