Gilead's Stribild, formerly "Quad," gets FDA nod

The US Food and Drug Administration has approved US biotech firm Gilead Sciences’ (Nasdaq: GILD) Stribild (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naive adults, previously referred to as “Quad.”

“Over the past decade, co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” said Paul Sax, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, Professor of Medicine at Harvard Medical School, and principal investigator of one of the Stribild pivotal studies, adding: “Today’s approval of Stribild will provide physicians and their patients an effectivee new single tablet treatment option for individuals starting HIV therapy for the first time.”

Under the terms of the FDA approval, the FDA stated, Gilead is required to conduct additional studies to help further characterize the drug’s safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs.