- Gilead's second TAF-based HIV-1 treatment won FDA approval on Monday, several months after the regulator approved the HIV combination med Genvoya in November 2015.
- Marketed as Odefsey, this new treatment combines Gilead's emtricitabine and tenofovir alafenamide (TAF) with Janssen's rilpivirine. Odefsey's single tablet is the smallest pill of any HIV treatment regimen for HIV, according to Gilead.
- The FDA did require Odefsey to carry a boxed warning for risk of lactic acidosis, severe hepatomegaly with steatosis, and post-treatment exacerbation of Hepatitis B.
Odefsey is the latest approved drug using Gilead's successor tenofovir alafenamide, which has similar efficacy but with fewer side effects than the older tenofovir disoproxil (TDF). TDF is the main compound in Gilead's existing HIV med Viread.
Last week, Gilead announced the EMA had recommended EU approval for Descovy (emtricitabine/TAF), also for the treatment of HIV-1. The FDA is also reviewing Descovy which has a PDUFA date of April 7, 2016.
Gilead used a priority review voucher it had purchased from Kinght Therapeutics in order to speed the review of Odefsey, according to FierceBiotech.
The drug is approved for treatment of HIV-1 only in patients 12 years and older, with no history of antiretroviral therapy and RNA levels less than or equal to 100,000 copies/mL.