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Tricida Ready For FDA Filing With Long-Term Safety, Efficacy Data In CKD

 
• By Joseph Haas

Not only did Tricida’s Phase III long-term extension study show safety for TRC101 in CKD metabolic acidosis patients, but also promise in renal health outcomes. Biomedtracker voiced caution on those findings, though, due to study limitations.

Chronic Kidney Disease general health word cloud on chalkboard with stethoscope, health / medical concept. - Image

Tricida Inc. has completed all the pre-approval clinical studies it planned for TCR101 to treat metabolic acidosis in chronic kidney disease (CKD) patients and plans to file for US approval during the second half of 2019. But it thinks a long-term extension study also has indicated a renal health outcomes benefit that it will need to prove out in a post-marketing study.

The South San Francisco-based firm revealed March 28 that TCR101 (veverimer) – a first-in-class, oral, non-absorbed polymer – met the primary and secondary endpoints in the 196-patient, 40-week, placebo-controlled extension study of its 12-week, pivotal TRCA-301 study. Of 217 patients randomized into the 12-week study, 94

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