ViiV Boosted By Early GEMINI Data, But More Details Wanted
ViiV Healthcare has positive early pivotal data for its second two-drug regimen for HIV, but more reassurance is needed on the relative rates of virologic suppression in patients with low and high viral loads, as well as on the long-term risk of virologic failure. The combination should help form ViiV's defense against rival Gilead and its new triple combination Biktarvy.
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ViiV Healthcare intends to seek regulatory approval for a fixed-dose combination of Tivicay and Epivir later this year based on positive 48-week data from the GEMINI studies in treating HIV that analysts say have helped to lift key uncertainties about the treatment and boost ViiV's competitive position versus key rival Gilead Sciences, which has favored triplet therapy.
The likely EMA approval of Juluca challenges the traditional HIV treatment paradigm of a three-drug regimen, with the single tablet, two-drug regimen offering the same efficacy as well as reduced toxicity and greater convenience.
The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.