ViiV Healthcare submits extended approval request for tablet formulation of Triumeq for HIV to FDA

ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above to 14kg and above.

If approved, this approval will result in further treatment options for younger children living with HIV. This submission is based on modelled data and in line with regulatory guidance.