European Commission approves Rezolsta, a new once-daily, fixed-dose HIV therapy combining darunavir and cobicistat

Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of REZOLSTA^® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older.

The decision from the EC follows a Positive Opinion recommending the use of REZOLSTA^® from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2014.¹ At that time, the CHMP also announced two label indication extensions for darunavir, a protease inhibitor marketed as PREZISTA^® by Janssen, which have also been approved by the EC.^2,3

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 Sciences, Inc.). The Janssen marketing authorization application was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents,⁴ and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations.⁵ The tolerability profile of the fixed dose-combination is similar to that of the two agents taken separately.⁴

“This approval can be seen as another step forward for patients living with and receiving treatment for HIV,” said Christiane Moecklinghoff, M.D Ph.D, Medical Director, Virology, Janssen EMEA. “Progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life. REZOLSTA^® eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir, reducing the pill burden for patients.”

The two additional label indication extensions relating to darunavir approved by the EC, will now be implemented across Europe in line with local regulatory bodies. The first label indication extension is once-daily dosing of darunavir/ritonavir in children aged 3-<12 years in those who are ARV treatment-naïve as well as treatment-experienced, provided their virus is fully sensitive to drug, in combination with other ARVs.² This allows a once-daily dosing regimen of darunavir in children within this age group, adding to increased convenience in this pediatric population. The second label indication extension is for cobicistat as an alternate booster for darunavir in adults aged 18 years or older in combination with other ARVs,³ providing another booster option for darunavir in people living with HIV.

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 FDA in the USA.

Janssen will continue to make darunavir available, as a single agent in tablets, so patients and their physicians can decide which treatment regimen is best for them.

References

1. European Medicines Agency, Committee for Human Products for Medicinal Use. Summary of opinion: Rezolsta (darunavir/cobicistat). 25 September 2014. Available at: http://www.ema.europa.eu Last accessed November 2014.
2. European Medicines Agency, Committee for Human Products for Medicinal Use. Summary of opinion: Prezista (darunavir). 25 September 2014. Available at: http://www.ema.europa.eu Last accessed November 2014.
3. European Medicines Agency, Committee for Human Products for Medicinal Use. Summary of opinion: Prezista (darunavir). 25 September 2014. Available at: http://www.ema.europa.eu Last accessed November 2014.
4. Kakuda TN, Van De Casteele T, Petrovic R, et al. Bioequivalence of a darunavir/cobicistat fixed-dose combination tablet versus single agents and food effect in healthy volunteers. Antivir Ther. 2014 Jun 25. doi: 10.3851/IMP2814. [Epub ahead of print].
5. National Institutes of Health. Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults. NCT01440569. Available at: http://clinicaltrials.gov/show/NCT01440569 Last accessed November 2014.