The Conversation (0)
Cerecor Receives Fast Track Designation from FDA for CERC-802
Aug. 21, 2019 09:17AM PST
Biotech Investing
Cerecor (NASDAQ:CERC) has announced that the US Food and Drug Administration has granted the company fast track designation for CERC-802 to treat Mannose-Phosphate ISomerase Deficiency (MPI-CDG or CDG-1b). As quoted in the press release: “We believe that the granting of Fast Track designation for CERC-802 is another crucial step in the development of a potential …
Cerecor (NASDAQ:CERC) has announced that the US Food and Drug Administration has granted the company fast track designation for CERC-802 to treat Mannose-Phosphate ISomerase Deficiency (MPI-CDG or CDG-1b).
As quoted in the press release:
“We believe that the granting of Fast Track designation for CERC-802 is another crucial step in the development of a potential treatment for this ultra-rare condition,” said Dr. Simon Pedder, Executive Chairman of the Board for Cerecor. “We continue to work closely with the FDA to advance this development program forward expeditiously. We’re currently collecting retrospective data through the CDG FIRST trial to support a New Drug Application for a much-needed therapy.”
About CERC-802
CERC-802 is an ultra-pure formulation of D-mannose, a naturally occurring monosaccharide commonly found in animals, microorganisms, and plants, including edible fruits and herbs. D-mannose is consumed by the body to provide substrates for protein glycosylation, the process by which carbohydrates are utilized to modify certain proteins as it relates to protein structure and function. CERC-802 has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the FDA, making the Company eligible to receive a Priority Review Voucher (PRV) upon approval of an NDA.