REMS Requirement Removed for Gout Drug

The FDA deems the communication plan for Krystexxa completed
The FDA deems the communication plan for Krystexxa completed

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Krystexxa (pegloticase; Horizon) Injection.

The sBLA proposed modifications to the Risk Evaluation and Mitigation Strategy (REMS) and removal of the requirement for the approved REMS for Krystexxa. The REMS for Krystexxa was initially approved on September 14, 2010 with the most recent modification approved on July 30, 2015. The REMS included a communication plan and a timetable for submission of assessments of the REMS. 

RELATED: Gout Drug Effective in Patients With Renal Impairment

Based on the completed communication plan and most recent assessment submitted on September 14, 2015, the Agency determined it was no longer necessary to include it as part of the approved REMS in ensuring that the benefits of Krystexxa outweigh its risks. As a result, a REMS will no longer be required since the communication plan has met its goals. 

Krystexxa Injection, a PEGylated uric acid specific enzyme, is indicated for the treatment of chronic gout in adults refractory to conventional therapy. It is available as a 8mg/mL concentrate for dilution in 2mL single-use vials.

For more information call (888) 579-7839 or visit Krystexxa.com.

Loading links....