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8 recent FDA updates in gastroenterology, hepatology
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The FDA issued a number of important decisions relevant to gastroenterology and hepatology last month, including the approval of a swallowable intragastric balloon for weight loss, two single-use colonoscope systems and two new biologics for Crohn’s disease, one of which is the fourth approved biosimilar in the U.S.
Below, Healio Gastroenterology recaps 8 FDA updates from the month of September.
1. FDA approves Stelara for Crohn’s disease
The FDA has approved Stelara for the treatment of adults with moderate-to-severe active Crohn’s disease for whom previous therapies have failed, the manufacturer announced.
Stelara (ustekinumab, Janssen) is the first biologic for Crohn’s disease that targets interleukin (IL)-12 and IL-23 cytokines. Read more
2. FDA approves Amjevita, biosimilar to Humira
The FDA has approved Amjevita, a biosimilar to Humira, according to an FDA press release.
“This is the fourth FDA-approved biosimilar,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.” Read more
3. FDA develops new model to predict DILI severity
FDA researchers developed a novel and effective tool to determine drug-induced liver injury risk and assist in choosing drug development candidates, according to research published in Hepatology.
“A DILI score algorithm was developed that provides a scale of assessing the DILI risk in humans associated with oral medications,” Minjun Chen, PhD, of the National Center for Toxicological Research at the FDA, and colleagues wrote. Read more
4. FDA clears Aer-O-Scope with therapeutic access
The FDA has granted 510(k) clearance for the new Aer-O-Scope disposable colonoscopy system, which now includes working channels for therapeutic intervention during colorectal cancer screening, the manufacturer announced.
Aer-O-Scope (GI-View) is a single-use self-propelled colonoscope system that is the first to provide a 360 degree omni-directional view of the colon for detecting polyps behind folds, according to a press release. The update to the new system includes two working channels that provide therapeutic access using standard biopsy and polypectomy tools. Read more
5. FDA approves swallowable intragastric balloon for obesity
The FDA has approved the Obalon Balloon System, a swallowable intragastric balloon for weight loss in adults with obesity for whom diet and exercise has failed, the manufacturer announced.
The Obalon Balloon System (Obalon Therapeutics) involves a balloon folded within a capsule that is swallowed and inflated with gas by a micro-catheter once it reaches the stomach, according to a press release. Two additional balloons are then swallowed and inflated over the next 3 months, and all three balloons are then endoscopically removed after the 6-month treatment period. Read more
6. FDA grants orphan drug designation to BIV201 for most ascites treatments
The FDA granted BioVie Inc. orphan drug designation for BIV201 for the treatment of ascites in all instances except those caused by cancer, according to the company.
“Orphan drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy,” Jonathan Adams, CEO at BioVie, said in a press release. “It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients.” Read more
7. FDA clears phase 2 trial of drug candidate for ileus, adhesions
The FDA has cleared the initiation of a phase 2 clinical trial of LB1148, a drug candidate for postoperative ileus and abdominal adhesions, the manufacturer announced.
LB1148 (Leading BioSciences) is a broad-spectrum serine protease inhibitor designed to protect the mucosal barrier of the intestine to prevent digestive enzymes from escaping, which can lead to acute shock, multiple organ failure, postoperative ileus, surgical adhesions and other conditions with limited or no treatment options, according to a press release. Read more
8. FDA clears single-use colonoscopy scope
The FDA has granted 510(k) clearance to the invendoscopy E200 system, which includes the first and only sterile, single-use colonoscope, the manufacturer announced.
The disposable invendoscope SC200 (invendo medical) eliminates the need for scope reprocessing, which is costly, time consuming and carries a risk for microbial cross-contamination between patients, according to the press release. Read more