Tuesday, August 13, 2013

GSK and Shionogi receive USFDA approval for Doluetagravir (Tivicay)

ViiV healthcare announced that they have received  US approval of Tivicay (Dolutegravir). The label is broad and includes Treatment naïve, treatment experienced HIV patients and also 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).   

Tivicay should be able to quickly penetrate in the INSTI resistance patient pool. Also by virtue of a best in class clinical profile, we also expect it to gain acceptance in the the treatment naïve patient pool.  

Whether or not dolutegravir can be a multi-billion dollar drug, depends on its ability to replace Atripla. In the SINGLE trial, dolutegravir in combination with Epzicom was able to demonstrate superiority over Atripla in terms of efficacy. The superiority was primarily driven by a lower discontinuation rate.

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