Valeant Pharmaceuticals Intl Inc VRX shares gained 2 percent Monday morning after the company confirmed the Food and Drug Administration approved its bowel-cleansing preparation product.
What Happened
Valeant said the FDA granted approval for PLENVU, the company's polyethylene glycol-based bowel preparation. Plenvu, made by the company's fully owned subsidiary Salix, is intended to be used ahead of colonoscopies for the early detection and prevention of colon cancer.
Why It's Important
Most patients indicate the preparation for colonoscopies are more burdensome than the medical process itself, Valeant said in the press release. The large volume of liquid required to drink coupled with the "unpleasant" taste is among the among the biggest barriers to colonoscopies. The company's Plenvu is a low volume — 1-liter — polyethylene glycol based bowel preparation that focuses on the ascending colon.
Approximately 97,000 new cases of colon cancer and 43,000 cases of rectal cancer are found each year, Valeant said. Successful and early detection of colorectal cancer screening helps to save lives, and the company hopes to play a role with the lowest total-volume preparation bowel cleanser available in the U.S.
What's Next
Plenvu's approval by the FDA gives Valeant the right to begin marketing its product in the U.S. product as soon as the third quarter of 2018.
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