FDA Will Review BioLink’s New Drug for Treatment of Hyperphosphatemia of End-stage Kidney Disease

Share Article

Approval of This Novel Phosphate Binder Will Be a Major Milestone for the Company

Company logo

Novel treatments for chronic diseases

New drug has potential to maintain quality of patient care while keeping costs down.

BioLink Life Sciences, Inc., a biopharmaceutical innovator, announced today that the U.S. Food & Drug Administration (FDA) has accepted its New Drug Application for PiLo™ (calcium succinate capsules) for review. PiLo™ is the Company's patented phosphate binder for the treatment of elevated blood phosphate in patients with end stage renal disease (ESRD).

Upon FDA approval, the Company expects PiLo™ to provide a cost-saving replacement for current FDA-approved drugs treating hyperphosphatemia in ESRD patients. Because calcium succinate does not form volatile gasses (e.g., vinegar or carbon dioxide), PiLo™ is expected to reduce serious side effects, such as irritation of the gastrointestinal tract, associated with other calcium based products. Moreover, if approved by the FDA, the use of PiLo™ could potentially delay conversion to resin-based phosphate binders which are often ten times more expensive than calcium-based products. Numerous published clinical studies have shown that calcium-based phosphate binders are as effective as resin based products in reducing levels of serum phosphate and do not, contrary to claims by some sellers of resin-based products, add to the risk of vascular calcification in ESRD patients.

About PiLo™

PiLo™ is an oral phosphate binder indicated for the reduction of excess levels of serum phosphorus (hyperphosphatemia) in patients with end stage renal disease (ESRD). PiLo™ traps dietary phosphate before it is taken up by the body, an action that may slow disease progression.

About Chronic Kidney Disease

Chronic kidney disease (CKD) affects over 36 million Americans and is the ninth leading cause of death. Over 500,000 CKD patients have progressed to kidney failure (ESRD) and are treated by kidney dialysis. The vast majority of these ESRD patients have hyperphosphatemia. Patients with ESRD have “universal” healthcare coverage under Medicare and the costs of their care consume over 25% of the Medicare budget. CKD is a growing healthcare concern, since the costs of patient care are high and obesity, diabetes, and hypertension often culminate in CKD and ultimately ESRD. In response to the high costs of treating ESRD patients who must undergo dialysis, Medicare has mandated that drugs related to their dialysis treatment will be “bundled” into the amount that Medicare will pay to providers of dialysis services as of January 2014. A safe, effective drug for hyperphosphatemia such as PiLo™ could result in significant cost savings.

About BioLink Life Sciences

BioLink Life Sciences is a biopharmaceutical technology company targeting major diseases with innovative drug treatments. BioLink’s exclusive drug therapies support disease management initiatives to enhance the quality of life and care of patients while improving patient tolerability and decreasing drug costs. The Company is developing a robust pipeline of novel treatments for iron deficiencies, kidney disease, diabetes, and seizure disorders. BioLink is also an established leader in providing contract research and technical support for health care companies developing drugs, biological, dietary supplements, and medical devices. More information can be found at http://www.biolinkonline.com or by calling the Company at 01-919-678-9478.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Deanna Nelson
Visit website