Biotech

Cerecor (NASDAQ:CERC) has announced that the US Food and Drug Administration (FDA) has designated fast track designation for CERC-901, an oral formulation of D-galactose in development for treating Phosphoglucomutase. As quoted in the press release: “We believe that receiving Fast Track designation for CERC-801 reinforces the high unmet need that currently exists for this ultra-rare …

Cerecor (NASDAQ:CERC) has announced that the US Food and Drug Administration (FDA) has designated fast track designation for CERC-901, an oral formulation of D-galactose in development for treating Phosphoglucomutase.

As quoted in the press release:

“We believe that receiving Fast Track designation for CERC-801 reinforces the high unmet need that currently exists for this ultra-rare condition affecting children with Congenital Disorders of Glycosylation,” said Peter Greenleaf, Chief Executive Officer of Cerecor. “We continue to work tirelessly to expedite this development program and work with the regulatory authorities in gaining an approval for a much-needed therapy for patients and families suffering from PGM1 deficiency.”

About CERC-801

CERC-801 is an ultra-pure formulation of D-galactose, a naturally occurring monosaccharide found in dairy products and fruit. D-Galactose 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-801 has been granted Orphan Drug Designation (ODD) and awarded Rare Pediatric Disease Designation by the FDA, granting eligibility for receipt of a Priority Review Voucher (PRV) upon approval of an New Drug Application (NDA).

Fast Track Designation

Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.

Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program. These can include meetings to discuss study design, data required to support approval, or other aspects of the clinical program. Additionally, products that have been granted Fast Track Designation may be eligible for priority review of NDA and the FDA may consider reviewing portions of a NDA before the sponsor submits the complete application (Rolling Review).

Click here to read the full press release.

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