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SHIONOGI - Tivicay (Dolutegravir) US Approval Comes with an Encouraging Broad Label. Focus Shifts on Data from FLEMINGO Study and Approval of Trii FDC! - new market research report published
SHIONOGI - Tivicay (Dolutegravir) US Approval Comes with an Encouraging Broad Label. Focus Shifts on Data from FLEMINGO Study and Approval of Trii FDC! - a new market research report on 2014-04-17 04:40:03
ViiVhealthcare today announced US approval of Tivicay (Dolutegravir) - it is approved both for treatment naïve and treatment experienced HIV patients and also in INSTI (integrase strand transfer inhibitor) resistance patients (except in patients where INSTI-resistance is due to Q148 substitution plus two or more additional INSTI resistance substitution).

This will allow Tivicay to initially grab the INSTI resistance patient pool and a share from treatment naïve patient pool (naïve patients stay on therapy longer). We forecast $750m peak sales for Tivicay in this segment. Recently launched Stribild (Gilead, in 2Q12 in treatment naïve patients) has attained sales of $191m in the 1H 2013.

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