This article is more than 5 years old. Information may no longer be current.
FDA to review new drug application for Duzallo
Click Here to Manage Email Alerts
Ironwood Pharmaceuticals announced the FDA has accepted to review the new drug application for Duzallo, a fixed-dose combination of lesinurad and allopurinol for the treatment of hyperuricemia in patients with uncontrolled gout, according to a press release.
If the FDA Prescription Drug User Free Act becomes approved in the second half of 2017, Duzallo is expected to become commercially available in late 2017, the release noted.
The dual mechanism of the therapy can address both inefficient renal excretion of uric acid and overproduction of uric acid. As most patients with uncontrolled gout are often treated with doses of xanthine oxidase inhibitors that require multiple pills per day to reach target serum uric acid levels, Duzallo would become the first dual-mechanism treatment to only require a single daily pill.
The new drug application — submitted by Ardea BioSciences on behalf of Ironwood — was based on the efficacy and safety data of the two individual drugs, demonstrated in the CLEAR 1 and CLEAR 2 phase 3 trials, as well as pharmacokinetic bioequivalence data of the fixed-dose combination compared with administration of the individual tablets.
Reference:
http://news.ironwoodpharma.com/phoenix.zhtml?c=228069&p=irol-newsArticle&ID=2233799