Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tybost, 150 mg, film-coated tablet intended for use as a pharmacokinetic enhancer of the human immunodeficiency virus-1 ( HIV-1 ) protease inhibitors Atazanavir and Darunavir in adults.
The active substance of Tybost is Cobicistat, a PK enhancer and is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
The benefits with Tybost are its ability to inhibit CYP3A-mediated metabolism and to enhance the systemic exposure of CYP3A substrates ( such as Atazanavir or Darunavir ) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism.
The most common side effects with Cobicistat-boosted Atazanavir are associated with elevated bilirubin levels.
The approved indication is: Tybost is indicated as a pharmacokinetic enhancer of Atazanavir 300 mg once daily or Darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 ( HIV-1 ) infected adults.
It is proposed that Tybost be prescribed by physicians experienced in the management of HIV infection.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Tybost. ( Xagena )
Source: European Medicines Agency ( EMA ), 2013
XagenaMedicine_2013
