1. Scrip
  2. >>New Products

Reata Puts Hopes On Partner Study To Support Bardoxolone Resubmission

 
• By Joseph Haas

Reata says partner Kyowa Kirin’s outcomes study of bardoxolone in chronic kidney disease may address the questions cited by the FDA in its complete response letter for Alport syndrome.

CKD Reata image
CRL is Reata's latest setback in R&D for rare forms of chronic kidney disease • Source: Alamy

Reata Pharmaceuticals, Inc. is hoping that it will be able to provide the additional information sought in the US Food and Drug Administration’s complete response letter on bardoxolone for Alport syndrome from an outcomes study by partner Kyowa Kirin Co., Ltd., the firm told its quarterly earnings call on 28 February. But the outcomes trial, which is expected to report data during the second half of 2022, is in diabetic kidney disease.

The CRL on 25 February was not a complete surprise, as the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously at its 8 December meeting against approval of bardoxolone,...

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 New Products

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By Kevin Grogan

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 
• By Alexandra Shimmings

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

More from Scrip

Quotables: Pharma Leaders On The Month’s Hot Topics

 
• By Anabel Costa-Ferreira

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 
• By Sushmita Panda

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Astellas Gets CLDN.18.2-Targeted ADC From China’s Evopoint

 
• By Joseph Haas

Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.