AstraZeneca (AZN) Announces FDA Acceptance of Sodium Zirconium Cyclosilicate NDA Resubmission
- Wall Street falls as investors ready for Trump's inauguration
- IBM (IBM) Tops Q4 EPS by 13c, FY17 EPS Guidance Beats Consensus
- American Express (AXP) Misses Q4 EPS by 7c, FY17 EPS Guidance Tops Views at Mid-Poinit
- Skyworks Solutions (SWKS) Tops Q1 EPS by 3c, Offers Q2 Guidance, Announces Buyback
- After-Hours Stock Movers 01/19: (SWKS) (QRVO) (NVAX) Higher; (AFMD) (SGYP) (IBM) Lower (more...)
Get inside Wall Street with StreetInsider Premium. Claim your 2-week free trial here.
AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete class 2 response.
Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.
About sodium zirconium cyclosilicate (ZS-9) for oral suspension
Sodium zirconium cyclosilicate (ZS-9) is an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions. Sodium zirconium cyclosilicate has been studied in three double-blind, placebo controlled trials and in one ongoing 12-month open label clinical trial in patients with hyperkalaemia which represents over 1,600 patients treated. Sodium zirconium cyclosilicate is an investigational medicine that is not currently approved for any indication in any market.
Hyperkalaemia (potassium levels > 5.0 mEq/L in the blood serum) commonly occurs in patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death. Treatment with common heart medicines (RAAS inhibitors) can also be responsible for increases in hyperkalaemia. Current therapeutic options are limited, leaving a high unmet medical need in these patients.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- AstraZeneca (AZN) MYSTIC Change Positive for Merck (MRK), Less so for Bristol-Myers Squibb (BMY) - BMO
- Catabasis Pharma (CATB) Edasalonexent Phase 1 Data Published for DMD in the Journal of Clinical Pharmacology
- Texas Instruments (TXN) Names Todd Bluedorn to Board of Directors
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!