1. Scrip
  2. >>Therapy Areas
  3. >>Genitourinary

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Genitourinary

Still Looking For A Gene Therapy Hit, Syncona Backs Purespring In IgA Nephropathy Market

 
• By Andrew McConaghie

Purespring has just raised $105m from an investor syndicate who are betting it can develop the first gene therapy for kidney disease and learn from setbacks experienced in the space.

REGENCY Dandy for Roche In Lupus Nephritis

 
• By Elizabeth Cairns

Gazyva could add the autoimmune condition to its label following a Phase III hit, but it might struggle to differentiate itself from Benlysta and Lupkynis.    

AstraZeneca Believes Size Matters In Amyloidosis

 
• By Elizabeth Cairns

Following the pivotal data on Alnylam’s Amvuttra, all eyes turn to the next amyloidosis readout – that of AstraZeneca and Ionis’ Wainua. And the UK major’s ambitions do not stop there.    

Pfizer And Flagship’s Quotient To Seek Out New Heart And Kidney Drugs

 
• By Andrew McConaghie

The big pharma’s second selection in the alliance shows novel cardiovascular therapies are high on its priority list

More from Therapy Areas

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 
• By Jessica Merrill

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By Kevin Grogan

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.