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Acer submits new drug application for rare disease to FDA

Park Gi-taek  Published 2018.10.31  15:55  Updated 2018.10.31 15:55

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Acer Therapeutics, a NASDAQ-listed pharmaceutical firm in which Bukwang Pharm has a 6.5 percent stake, has submitted a New Drug Application (NDA) for a rare disease treatment to the Food and Drug Administration, Bukwang said. The drug, Edsivo, treats vascular Ehlers-Danlos syndrome (vEDS),

Acer also requested Priority Review for the treatment.

The FDA grants Priority Review to a therapy that provides a significant improvement in treatment or if there is no alternative therapy.

VEDS is a rare disease that a genetic defect causes abnormal formation of collagen. In a severe case, it can lead to vascular rupture and death. There is no cure for the disease.

The FDA designated Edsivo as an orphan drug for the potential treatment of vEDS in 2015.

Acer Therapeutics focuses on developing medicines for ultra-rare diseases that have not been treated with existing therapies. The company has another pipeline called ACER-001 to treat maple syrup urine disease and urea cycle disorders. Next year, the company plans to submit NDA for ACER-001, too, Bukwang said.

pkt77@docdocdoc.co.kr

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