EMA approves coformulated atazanavir/cobicistat

1 June 2015. Related: Antiretrovirals.

EMA press release

On 21 May 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended approval in the EU for the combined formulation of atazanavir/cobicistat (300 mg/150 mg) film coated tablets.

The indication is for use with other antiretrovirals to treat HIV-1 in people without mutations associated with drug resistance to atazanavir.

This combines the protease inhibitor atazanavir with the PK booster cobicistat in a single pill. The brand name is Evotaz and it is manufacted by Bristol-Myers Squibb.

For full details see the summary of product characteristics (SmPC).

Source:

Committee for Medicinal Products for Human Use (CHMP). Evotaz Summary of opinion (initial authorisation). EMA/CHMP/277547/2015. (21 May 2015).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003904/smops/Positive/human_smop_000830.jsp&mid=WC0b01ac058001d127