Darunavir: new oral suspension and 800 mg formulations approved in EU
1 February 2013. Related: Antiretrovirals.
Two new formulations of darunavir were recently granted EU approval.
On 25 October 2012, the EU approved a 100 mg/ml oral suspension of darunavir (Prezista), and the use of darunavir co-administered with low dose ritonavir, in combination with other ARVS, for the treatment of HIV-1 in treatment-experienced paediatric patients age 3 years and above, weighing at least 15 kg body weight. [1]
The approval is based on a 48-week analysis of ARIEL, a Phase II, open-label trial to evaluate pharmacokinetics, safety, tolerability and antiviral activity of darunavir in combination with low dose ritonavir in treatment-experienced HIV-1 infected children from 3 to < 6 years of age.
The EU also recommended approval of the darunavir 100 mg/ml oral suspension for use in patients who are unable to swallow tablets, providing an additional way to receive treatment.
The EU approval for the oral suspension was also based on TMC114-C169: a Phase I open label randomised crossover trial in healthy participants to compare the oral bioavailability to that of the 300 mg tablet formulation with 100 mg ritonavir under fasted and fed conditions.
The second formulation, is an 800 mg darunavir tablet that reduces the pill count for standard daily adult dose from 2 x 400 mg to 1 x 800 mg tablet. Both formulations require boosting by 100 mg ritonavir.
Both are now available in the UK.
References:
- Jannsen-Cilag press release. Darunavir (Prezista) oral suspension receives EU approval for young children with HIV-1 infection. 25 October 2012.
- Jannsen-Cilag press release. FDA Approves New 800mg PREZISTA (darunavir) tablet. (9 November 2012).
http://www.jnj.com/connect/news/all/fda-approves-new-800mg-prezista-darunavir-tablet