FDA approves Gilead’s Odefsey

SILVER SPRING, Md. — The Food and Drug Administration has approved Gilead Sciences’ new drug Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg), the company announced Tuesday. 

 

This is Gilead’s second FDA approval for a drug regimen based on tenofovir alafenamide (TAF) and is the smallest pill for a single-tablet treatment for HIV, according to the company. TAF can enter cells, including those infected with HIV, more efficiently than that used in Gilead’s Viread (tenofovir disproxil fumarate, or TDF). 

 

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” Gilead chairman and CEO John Martin said. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

 

The drug comes with a boxed warning about the risk for lactic acidosis/severe hepatomegaly with steatosis, as well as post-treatment acute exacerbation of hepatitis B.