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Acer Therapeutics drug for rare disorder gets U.S. FDA priority review status


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Acer Therapeutics drug for rare disorder gets U.S. FDA priority review status

Acer Therapeutics Inc. medicine Edsivo to treat a rare inherited tissue disorder was granted priority review by the U.S. Food and Drug Administration.

Edsivo, or celiprolol, was developed to treat vascular Ehlers-Danlos syndrome, or vEDS, in patients who have mutations in a protein called type 3 collagen.

Ehlers-Danlos syndrome is a group of hereditary disorders of connective tissue, and vEDS is the most severe subtype of the disorder, in which patients have life-threatening arterial dissections and ruptures as well as intestinal and uterine ruptures. The average mortality age of patients with the condition is 51 years, and there is currently no approved treatment for the disease, according to the company.

The U.S. regulator grants priority status to accelerate the review process for drugs that offer a significant improvement over current therapies or where no satisfactory alternative treatment exists.

The FDA, which has accepted the new drug application, will decide by June 25, 2019, whether to approve the therapy.

Newton, Mass.-based Acer Therapeutics said it has started precommercial activities for Edsivo.