ition amounting to a severe gout syndrome, in a synthesis of
data derived from five studies: the pegloticase Phase 2 study, GOUT 1, 2,
and 3, and a 12-month non-interventional natural history study in
treatment-failure gout patients. This was the first time that the data from
these studies was presented in a scientific forum.
New Results presented at ACR:
-- The GOUT 3 study data demonstrated the continuing efficacy of
pegloticase in normalizing PUA to less than 6 mg/dL. It also
demonstrated the ability to maintain control of PUA for up to 18
months with continuous treatment in both the every 2 weeks and every 4
weeks treatment groups, in a proportion of patients similar to that
demonstrated in GOUT 1 and 2.
-- Gout Tophi: As previously reported by the Company, the superiority of
pegloticase administered every 2 weeks as compared to placebo in
attaining a gout tophus Complete Response was statistically significant
and clinically meaningful in the pegloticase 8mg every 2 weeks group
within 6 months of therapy, in the pre-specified pooled analysis.
Moreover, the tophus Complete Response was attained for the every 2
weeks group in both the GOUT 1 and GOUT 2 pivotal trials individually,
as well as in the pooled analysis. The pegloticase every 4 weeks group
attained statistical significance for tophus Complete Response in the
pre-specified pooled analysis. The analyses of secondary efficacy
endpoints for the individual studies as well as for the pooled data
across the two studies, has been included in the BLA submission for FDA
review.
The GOUT 3 data presented at ACR provided continued evidence of the
increase in pegloticase's favorable effect on achieving a Complete
Response for tophus resolution that was demonstrated in the initial 6
months of treatmen
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SOURCE Savient Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved | |
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