Positive opinion to approve of darunavir/cobicistat in Europe
1 October 2014. Related: Antiretrovirals.
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]
References:
- European Union CHMP. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014. (26 September 2014).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/09/news_detail_002170.jsp&mid=WC0b01ac058004d5c1 - PR Newswire. Prezcobix now available for Canadians living with HIV. (17 September 2014).
http://www.prnewswire.com/news-releases/prezcobix-now-available-for-canadians-living-with-hiv-275413881.html