CHMP gives positive opinion for HIV drug Rezolsta

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Rezolsta (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) in adults.

It also announced two label extensions for darunavir, a protease inhibitor marketed as Prezista.

Rezolsta is a new once-daily, fixed-dose combination tablet containing darunavir and the pharmacokinetic enhancing or ‘boosting’ agent cobicistat (marketed as Tybost by Gilead).

Dr Christiane Moecklinghoff, medical director, virology, Janssen EMEA, said that expanding existing treatment options through simplifying regimens and supporting adherence was critical. “If approved, this new treatment option eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir, reducing the pill burden for patients. We look forward to a final decision from the European Commission in the coming months,” she stated.

The darunavir and cobicistat fixed-dose combination was approved in Canada in June 2014 under the name Prezcobix, and is currently undergoing regulatory review by the US FDA.

Darunavir will also remain available as a single agent in tablets.

The CHMP has also issued two additional label extensions relating to darunavir. The first is for the prescribing of once-daily dosing of darunavir/ritonavir in children aged three to 12 who are antiretroviral (ARV) treatment-naïve as well as treatment-experienced, provided their virus is fully sensitive to the drug, in combination with other ARVs. The second is for the prescribing of cobicistat as an alternate booster for darunavir in adults in combination with other ARVs.

Darunavir received initial approval in Europe in 2007 for use in HIV-1 infected highly pre-treated patients, with later approvals for treatment-naïve and less experienced adult patients, and then for use in paediatric patients. Darunavir/ritonavir is approved for use in paediatric patients aged three to 17.

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Janssen seeks European approval of HIV combination drug

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