Positive opinion to approve of darunavir/cobicistat in Europe

Simon Collins, HIV i-Base

On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorisation for a coformulated version of darunavir (800 mg) plus the pharmacokinetic booster cobicistat (150 mg). [1]

The indication is for use in treatment-naive and treatment-experienced adults with no darunavir-associated mutations.

This formulation be the first single-pill, once-daily, boosted protease inhibitor for rich countries (as there is a generic atazanavir/ritonavir).

The same meeting also extended the indication for darunavir to include boosting with either ritonavir or cobicistat. [1]

Recommendations from the CHMP are usually followed with full approval, expected within three months.

The formulation is manufactured by Janssen-Cilag and will be marketed in Europe with the brand name Rezolsta. It is already available in Canada under the trade name Prezcobix. [2]


  1. European Union CHMP. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014. (26 September 2014).
  2. PR Newswire. Prezcobix now available for Canadians living with HIV. (17 September 2014).

Links to other websites are current at date of posting but not maintained.