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New Colonoscopy Dye Product Receives PDUFA Date
The manufacturer of a novel blue dye application for improved adenoma detection and visualization during colonoscopy announced the FDA accepted its new drug application and set a PDUFA for the product.
Aries Pharmaceuticals Inc. released an announcement that Methylene Blue MMX, a blue dye drug candidate to be taken prior to colonoscopy, received May 21, 2018, as its PDUFA date. The novel delivery application developed by Cosmo Pharmaceuticals and to be distributed by Aries allows for “sustained dye contact” in the colon wall and increases visibility of abnormal areas, according to the release.
“Increases in ADR have important clinical relevance,” Michael B. Wallace MD, MPH, of Mayo Clinic Florida, said in the release. “We know that for each 1% increase in ADR, a 3% decline in the incidence of interval cancer and a 5% decline in the incidence of fatal colorectal cancer (CRC) should be expected. MB MMX has the potential to provide gastroenterologists with a significant new means to improve their ADR and potentially help reduce colorectal cancer rates in the United States.”
According to Aries’ release, MB MMX identified 17.71% more patients with adenomas or carcinomas than standard of care high-definition white light colonoscopy (P = .009) in a recent phase 3 trial, which is expected to be published next year.
Disclosures: Wallace reports acting as a consultant for Cosmo Pharmaceuticals, Lumendi and Olympus; and receiving grant or research support from Boston Scientific, Cosmo Pharmaceuticals, Fujinon and NinePoint.