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Solidly Positive Phase III Data Boost Keryx’ Struggling Iron Drug Auryxia

 
• By Emily Hayes

Keryx set to pursue expanded FDA labeling of its phosphate binder Auryxia to pre-dialysis patients with iron deficiency, a patient population already approved for treatment in Europe.

Keryx Biopharmaceuticals Inc. is looking to submit a supplemental NDA in the third quarter for its oral phosphate binder Auryxia (ferric citrate) for an earlier line of treatment – pre-dialysis kidney disease patients with iron deficiency anemia – after reporting positive top-line Phase III results on March 29.

The non-calcium-based phosphate binder was approved in September 2015 for controlling serum phosphate levels, or hypophosphatemia, in patients with chronic...

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• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
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Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

BIO Notebook: PRVs Need To Be A Priority, IPO Window Shut And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.