US panel review for Savient's gout therapy pegloticase
This article was originally published in Scrip
Executive Summary
The US FDA's arthritis advisory committee will meet on March 5th to consider Savient Pharmaceuticals' pegloticase for treatment-failure gout. The BLA has orphan designation and is undergoing a priority review, with a user fee date of April 30th.
The US FDA's arthritis advisory committee will meet on March 5th to consider Savient Pharmaceuticals' pegloticase for treatment-failure gout. The BLA has orphan designation and is undergoing a priority review, with a user fee date of April 30th.
Pegloticase is Savient's leading candidate in development. It is a pegylated recombinant mammalian urate oxidase, intended to control hyperuricemia and its clinical consequences in patients for whom conventional therapy, such as allopurinol, is ineffective or contraindicated. Savient licensed worldwide rights to the technology from Duke University and Mountain View Pharmaceuticals.
The BLA is based on two six-month Phase III studies, GOUT 1 and GOUT 2, and data from a 12-month open label extension study, OLE/GOUT 3.
In November the FDA's arthritis panel overwhelmingly endorsed approval of Takeda's gout treatment Uloric (febuxostat, licensed from Teijin Pharma) but said postmarketing clinical and observational studies should be required to monitor the agent's long-term cardiovascular safety. The January user fee date for Uloric passed without FDA action, and Takeda said the agency was still completing inspections of investigator sites and a contract research organisation.