RTP pharma company receives FDA fast-track status

07/25/2014 4:57 PM

07/25/2014 4:58 PM

The Food and Drug Administration has given fast-track status to a treatment called HumaGraft being developed by Humacyte, a Research Triangle Park pharmaceutical company.

The fast-track designation means that FDA officials will have increased communication with company executives throughout the development process and facilitate a speedy review when a New Drug Application is submitted. The application will also be eligible for “rolling review” in which parts of the form are approved earlier than usual.

HumaGraft is intended for patients undergoing hemodialysis, a treatment process that performs the job of the kidneys. The treatment filters a few ounces of blood at a time, removing excess water and waste, then returns the blood to the patient’s body. Hemodialysis is the leading treatment for patients with kidney failure which is the last stage of chronic kidney disease.

HumaGraft is intended to improve treatments for hemodialysis patients by providing reliable vascular access. It is also expected to minimize certain complications that exist with current treatments.

“The fast track designation for HumaGraft recognizes the significant unmet need that exists and provides options for vascular access in hemodialysis patients,” CEO Carrie Cox said in a statement.

Humacyte, a private company, is conducting an investigational trial for the treatment in Poland and has recruited participants for two studies in the United States and Europe.

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