8 Recent FDA Updates in Gastroenterology

Issue: October 2015

The FDA has recently issued a number of gastroenterology-relevant communications, including bariatric and esophageal ablation device approvals, orphan drug designations for several cholangiocarcinoma treatments, fast track designation for a familial adenomatous polyposis drug, a draft guidance on clinical evaluation of gastroparesis drugs, and additional safety measures for ERCP duodenoscope reprocessing.

Here are the eight most recent FDA news stories presented by Healio Gastroenterology.

1. FDA: Balloon device for obesity treatment recently approved

On July 28, the FDA approved the ReShape Integrated Dual Balloon System, a new balloon device to treat obesity without invasive surgery in adults.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions, including efforts to improve diet and exercise habits,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the release. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can easily be removed.” Read more

2. FDA approves two new ablation systems for Barrett's esophagus

The FDA has granted 510(k) clearance to C2 Therapeutics’ Coldplay Cryoballoon Full Ablation System and its Cryoballoon Swipe Ablation System for the treatment of Barrett’s esophagus, the manufacturer announced on July 29.

“The U.S. regulatory clearance of the promising Coldplay Full and Swipe Ablation Systems is a major leap forward in the care of patients with Barrett’s esophagus at risk for development of esophageal cancer,” George Triadafilopoulos, MD, clinical professor of gastroenterology and hepatology at Stanford University, said in a press release. “These technologies provide endoscopists with more options to eliminate Barrett’s esophagus and improve patient outcomes.” Read more

3. FDA issues additional safety measures for ERCP devices

In an FDA Safety Communication report issued on August 4, the FDA provided supplemental measures for enhancing duodenoscope reprocessing for hospitals and health care facilities that use duodenoscopes, in an effort to continue reducing the risk of infection and increase the safety of endoscopic retrograde cholangiopancreatography medical devices. Read more

4. FDA issues draft guidance on clinical evaluation of gastroparesis drugs

The FDA issued a draft guidance on July 22 on trial designs and endpoints for clinical evaluation of gastroparesis drugs.

“The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic and idiopathic gastroparesis,” the FDA wrote in the draft guidance. Read more

5. FDA approves Orbera intragastric balloon for weight loss in obese adults

The FDA approved the Orbera intragastric balloon for weight loss in obese adults with a BMI of 30 to 40 for whom invasive surgery is not an option and for whom diet, exercise or medications have not worked, the manufacturer announced on August 6.

“While new to the United States, Orbera [Apollo Endosurgery] is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results,” Todd Newton, CEO of Apollo Endosurgery, said in a press release. Read more

6. FDA grants fast track designation to CEQ508 for familial adenomatous polyposis

The FDA granted fast track designation to CEQ508, an investigational RNAi therapeutic for familial adenomatous polyposis, the manufacturer announced on August 5.

According to a press release, the manufacturer also received a U.S. patent allowance covering the delivery technology for CEQ508 (transkingdom RNA interference [tkRNAi], Marina Biotech), which covers a range of vectors for bacterial mediated gene silencing and fundamental invasive bacterium for delivering RNA therapeutics. Read more

7. FDA grants orphan drug designation to varlitinib for cholangiocarcinoma

The FDA granted orphan drug designation to varlitinib (ASLAN001; ASLAN Pharmaceuticals, Array BioPharma) — an oral, novel pan-HER inhibitor — for the treatment of patients with cholangiocarcinoma, the manufacturer announced on August 13.

“In addition to our work in cholangiocarcinoma, we are progressing our portfolio of immunotherapies and targeted agents in other Asia-prevalent tumor types, including gastric cancer and hepatocellular carcinoma,” Carl Firth, PhD, CEO of ASLAN Pharmaceuticals, said in a press release. Read more

8. FDA grants orphan drug designation to melphalan for cholangiocarcinoma

The FDA granted orphan drug designation to melphalan (Melphalan/HDS, Delcath) for the treatment of patients with cholangiocarcinoma, the manufacturer announced on July 20.

“We are pleased with the receipt of orphan drug designation for melphalan in the treatment of patients with cholangiocarcinoma as it is a key milestone that supports our broader regulatory and development strategy for our Melphalan/Hepatic Delivery System as a therapy for primary and metastatic liver cancers," Jennifer Simpson, PhD, MSN, CRNP, president and CEO of Delcath Systems, said in a press release. Read more