dm+d

Unassigned

New Medicines

DuzalloHyperuricaemia in patients with gout

Information

Duzallo
New formulation
Grunenthal
Ironwood

Development and Regulatory status

Licensed but not launched
Approved (Licensed)
Launched
Dec 19The company has no plans to launch in the UK [10].
Jan 19Has been available in the US since Oct 17. Despite announcing plans to launch in most EU countries, UK launch appears to be unlikely [7-9].
Dec 18Grunenthal plans to launch allopurinol/lesinurad for Gout in most European countries in 2019 [7]
Aug 18Approved in the EU [6].
Jun 18Recommended for EU approval by CHMP - the full indication is "in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone."[5].
Aug 17Ironwood announces that the FDA has approved allopurinol + lesinurad (Duzallo) "as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone." The company expects US commercial availability early in the fourth quarter of 2017 [4].
Jul 17Filed in EU via centralised procedure [2].
Oct 16Ironwood Pharmaceuticals and AstraZeneca submit an NDA application for the fixed dose combination of allopurinol/lesinurad to the US FDA. The agency accepted for review the NDA application in Jan 2017. Ironwood excepts the PDUFA target action date to occur in 2H 2017. Once approved, Ironwood Pharmaceuticals intends to launch the fixed dose combination product in the US by late 2017 [3].

Category

Fixed-dose combination of allopurinol 300mg (a xanthine oxidase inhibitor) and lesinurad 200mg (a urate transporter, URAT1, inhibitor).
A study of UK general practice found that the prevalence of gout was 1.4%, the overall ratio of men to women was 3.6:1, and the annual incidence of gout ranged from 1.19-1.80 cases per 1,000 person-years [1].
Hyperuricaemia in patients with gout
Oral

Trial or other data

Feb 17Ardea Biosciences completes a PI trial to evaluate the bioequivalence of allopurinol/lesinurad 300/200mg FDC tablet and co-administered lesinurad 200mg and allopurinol 300mg in fed healthy volunteers (NCT02888054). The randomised, crossover, open-label, replicate trial recruited 28 volunteers in the US [3].
Aug 16Ardea Biosciences complete a two-part phase I trial, which evaluated the relative bioavailability of allopurinol/lesinurad 300/200mg FDC tablet and co-administered lesinurad 200mg and allopurinol 300mg in fasted subjects (Part 1) and the effect of food on the pharmacokinetics of the FDC tablet in healthy male volunteers (Part 2) ( NCT02581553). The randomised, crossover, open-label trial recruited 74 volunteers in the US [3].

Evidence based evaluations