2014 FDA approvals in gastroenterology

A large number of new drugs and devices for a wide variety of indications in gastroenterology were approved by the FDA in 2014, ranging from advanced endoscopic imaging devices to multiple new drugs for inflammatory bowel disease, hepatitis C and gastrointestinal cancers.

Below we present a timeline of the most important FDA approvals in 2014 covered by Healio Gastroenterology

FDA approved capsule endoscopy device for visualization of the colon

The FDA approved a capsule endoscopy device for visualization of the colon, giving PillCam COLON clearance under the direct denovo classification for devices with low to moderate risk that have no predicate in the marketplace, the manufacturer announced on February 3.

According to an announcement by Given Imaging Ltd., the device is designed to detect colon polyps in patients “after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.” Read more 

FDA approved Entyvio for ulcerative colitis, Crohn’s disease

In May, the FDA approved vedolizumab injections for the treatment of adult patients with moderate to severe ulcerative colitis and Crohn’s disease who failed to achieve adequate results from standard therapies, according to a press release.

“Ulcerative colitis and Crohn’s disease are debilitating diseases that impact the quality of life of those who have these conditions,” Amy G. Egan, MD, MPH, acting deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release. “Although there is no cure for these conditions … approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms.” Read more 

FDA approved Cyramza for stomach cancer

Richard Pazdur, MD

Richard Pazdur

The FDA approved ramucirumab for treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma in April 2014.

Ramucirumab (Cyramza, Eli Lilly), an angiogenesis inhibitor that blocks the blood supply to tumors, is indicated for patients with unresectable disease, or for those whose disease metastasized after treatment with platinum- or fluoropyrimidine-containing therapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.” Read more 

FDA approved Movantik for opioid-induced constipation

The FDA approved naloxegol, an oral therapeutic indicated for opioid-induced constipation in adults with chronic noncancer pain, on September 16.

Naloxegol (Movantik, AstraZeneca) is a peripherally acting opioid receptor antagonist, a class of drugs used to mitigate the reduction of gastrointestinal motility commonly associated with opioid use.

“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release. Read more 

FDA approved Uceris foam for ulcerative colitis

William J. Sandborn, MD

William J. Sandborn

The FDA granted tentative approval for budesonide rectal foam for the induction of remission in patients with mild to moderately active distal ulcerative colitis in September, and granted final approval in October.

The approval follows two phase 3 studies that found “a significantly greater percentage of patients receiving Uceris 2 mg rectal foam achieved remission of distal ulcerative colitis at 6 weeks compared with placebo (41.2% vs. 24%),” according to a press release.

“These trials definitively demonstrated that Uceris rectal foam is an efficacious and well-tolerated rectal therapy for the induction of remission in patients with mild-to-moderate distal UC,” trial researcher William J. Sandborn, MD, chief of the division of gastroenterology, director of the IBD Center at University of California, San Diego, said in the release. Read more

FDA approved Humira for pediatric patients with Crohn’s disease 

The FDA approved adalimumab for the treatment of moderately to severely active pediatric Crohn’s disease in patients for whom other therapies had inadequate results, the manufacturer announced in late September.

“Moderate to severe Crohn’s disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives,” Jeffrey S. Hyams, MD, head of the division of digestive diseases, hepatology and nutrition, Connecticut Children’s Medical Center, said in the release. “The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease.” Read more

FDA approved Relistor for patients with opioid-induced constipation, chronic noncancer pain 

The FDA approved methylnaltrexone bromide subcutaneous injection for the treatment of opioid-induced constipation in patients taking opioids for chronic noncancer pain, the manufacturer announced in late September.

“Patients generally experience a rapid bowel movement following administration of methylnaltrexone, often within 30 minutes,” Eugene Viscusi, MD, director of acute pain management, department of anesthesiology at Thomas Jefferson University, Philadelphia, said in a press release. “Unlike laxatives, Relistor offers patients a relatively predictable timed response for a bowel movement. Additionally, most patients describe the sensation like a normal bowel activity. These attributes of treatment with Relistor are tremendous advantages.” Read more

FDA approved Harvoni for HCV treatment 

In October, Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration, according to an agency release.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.” Read more

FDA approved Pleximmune to predict risk for transplant rejection 

In November, the FDA approved a blood test used in predicting risk for transplant rejection in patients aged younger than 21 years who undergo liver or small bowel transplantation.

The test is intended for use in combination with other clinical information when managing anti-rejection therapy among patients with liver or small bowel transplants aged younger than 21 years. Read more

FDA approved new ‘panoramic’ imaging device for colonoscopy 

Jack Higgins, MD

Jack Higgins

The FDA issued 510(k) clearance in November to a novel dual-camera imaging device designed to help colonoscopists detect polyps behind folds in the wall of the colon, according to a company press release.

“We spent thousands of hours observing endoscopists as they performed colonoscopies using the Third Eye Retroscope, and we listened to their concerns regarding the ease of use,” Jack Higgins, MD, chief medical officer for Avantis, said in the release. “They liked the fact that additional cameras allowed them to see more of the colon, and they asked us to find a way to do that more easily and inexpensively, and without occupying the channels of their colonoscopes.” Read more

FDA approved simeprevir to be used with sofosbuvir for HCV genotype 1 

The FDA approved changes to the Olysio label reflecting that it can be used in combination with Sovaldi to treat patients with chronic hepatitis C virus genotype 1 infection, according to a media alert from the FDA in November.

Olysio (Simeprevir, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November of last year as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1. Read more

FDA approved Viekira Pak for treatment of HCV 

Edward Cox, MD, MPH

Edward Cox

On December 19, the FDA approved a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis, according to a press release.

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.” Read more

FDA approved Aer-O-Scope colonoscope system 

The FDA granted 510(k) clearance for the Aer-O-Scope colonoscope system from GI-View, the manufacturer announced in early December.

“Aer-O-Scope provides reliable and safe colorectal cancer screening. It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer," Erwin Santo MD, head of the department of gastroenterology and liver diseases at Tel Aviv Sourasky Medical Center and principal investigator of the most recent Aer-O-Scope clinical trial, said in the press release. Read more 

FDA approved Somatuline Depot for gastroenteropancreatic neuroendocrine tumors

On December 16, the FDA approved lanreotide for treatment of patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The approval was based in part on results of a trial that included 204 patients with non-functioning gastroenteropancreatic neuroendocrine tumors. More than half of the patients (55%) had tumors that were outside of the pancreas. Read more

A large number of new drugs and devices for a wide variety of indications in gastroenterology were approved by the FDA in 2014, ranging from advanced endoscopic imaging devices to multiple new drugs for inflammatory bowel disease, hepatitis C and gastrointestinal cancers.

Below we present a timeline of the most important FDA approvals in 2014 covered by Healio Gastroenterology

FDA approved capsule endoscopy device for visualization of the colon

The FDA approved a capsule endoscopy device for visualization of the colon, giving PillCam COLON clearance under the direct denovo classification for devices with low to moderate risk that have no predicate in the marketplace, the manufacturer announced on February 3.

According to an announcement by Given Imaging Ltd., the device is designed to detect colon polyps in patients “after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.” Read more 

FDA approved Entyvio for ulcerative colitis, Crohn’s disease

In May, the FDA approved vedolizumab injections for the treatment of adult patients with moderate to severe ulcerative colitis and Crohn’s disease who failed to achieve adequate results from standard therapies, according to a press release.

“Ulcerative colitis and Crohn’s disease are debilitating diseases that impact the quality of life of those who have these conditions,” Amy G. Egan, MD, MPH, acting deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release. “Although there is no cure for these conditions … approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms.” Read more 

FDA approved Cyramza for stomach cancer

Richard Pazdur, MD

Richard Pazdur

The FDA approved ramucirumab for treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma in April 2014.

Ramucirumab (Cyramza, Eli Lilly), an angiogenesis inhibitor that blocks the blood supply to tumors, is indicated for patients with unresectable disease, or for those whose disease metastasized after treatment with platinum- or fluoropyrimidine-containing therapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.” Read more 

FDA approved Movantik for opioid-induced constipation

The FDA approved naloxegol, an oral therapeutic indicated for opioid-induced constipation in adults with chronic noncancer pain, on September 16.

Naloxegol (Movantik, AstraZeneca) is a peripherally acting opioid receptor antagonist, a class of drugs used to mitigate the reduction of gastrointestinal motility commonly associated with opioid use.

“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release. Read more 

FDA approved Uceris foam for ulcerative colitis

William J. Sandborn, MD

William J. Sandborn

The FDA granted tentative approval for budesonide rectal foam for the induction of remission in patients with mild to moderately active distal ulcerative colitis in September, and granted final approval in October.

The approval follows two phase 3 studies that found “a significantly greater percentage of patients receiving Uceris 2 mg rectal foam achieved remission of distal ulcerative colitis at 6 weeks compared with placebo (41.2% vs. 24%),” according to a press release.

“These trials definitively demonstrated that Uceris rectal foam is an efficacious and well-tolerated rectal therapy for the induction of remission in patients with mild-to-moderate distal UC,” trial researcher William J. Sandborn, MD, chief of the division of gastroenterology, director of the IBD Center at University of California, San Diego, said in the release. Read more

FDA approved Humira for pediatric patients with Crohn’s disease 

The FDA approved adalimumab for the treatment of moderately to severely active pediatric Crohn’s disease in patients for whom other therapies had inadequate results, the manufacturer announced in late September.

“Moderate to severe Crohn’s disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives,” Jeffrey S. Hyams, MD, head of the division of digestive diseases, hepatology and nutrition, Connecticut Children’s Medical Center, said in the release. “The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease.” Read more

FDA approved Relistor for patients with opioid-induced constipation, chronic noncancer pain 

The FDA approved methylnaltrexone bromide subcutaneous injection for the treatment of opioid-induced constipation in patients taking opioids for chronic noncancer pain, the manufacturer announced in late September.

“Patients generally experience a rapid bowel movement following administration of methylnaltrexone, often within 30 minutes,” Eugene Viscusi, MD, director of acute pain management, department of anesthesiology at Thomas Jefferson University, Philadelphia, said in a press release. “Unlike laxatives, Relistor offers patients a relatively predictable timed response for a bowel movement. Additionally, most patients describe the sensation like a normal bowel activity. These attributes of treatment with Relistor are tremendous advantages.” Read more

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FDA approved Harvoni for HCV treatment 

In October, Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration, according to an agency release.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.” Read more

FDA approved Pleximmune to predict risk for transplant rejection 

In November, the FDA approved a blood test used in predicting risk for transplant rejection in patients aged younger than 21 years who undergo liver or small bowel transplantation.

The test is intended for use in combination with other clinical information when managing anti-rejection therapy among patients with liver or small bowel transplants aged younger than 21 years. Read more

FDA approved new ‘panoramic’ imaging device for colonoscopy 

Jack Higgins, MD

Jack Higgins

The FDA issued 510(k) clearance in November to a novel dual-camera imaging device designed to help colonoscopists detect polyps behind folds in the wall of the colon, according to a company press release.

“We spent thousands of hours observing endoscopists as they performed colonoscopies using the Third Eye Retroscope, and we listened to their concerns regarding the ease of use,” Jack Higgins, MD, chief medical officer for Avantis, said in the release. “They liked the fact that additional cameras allowed them to see more of the colon, and they asked us to find a way to do that more easily and inexpensively, and without occupying the channels of their colonoscopes.” Read more

FDA approved simeprevir to be used with sofosbuvir for HCV genotype 1 

The FDA approved changes to the Olysio label reflecting that it can be used in combination with Sovaldi to treat patients with chronic hepatitis C virus genotype 1 infection, according to a media alert from the FDA in November.

Olysio (Simeprevir, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November of last year as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1. Read more

FDA approved Viekira Pak for treatment of HCV 

Edward Cox, MD, MPH

Edward Cox

On December 19, the FDA approved a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis, according to a press release.

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.” Read more

FDA approved Aer-O-Scope colonoscope system 

The FDA granted 510(k) clearance for the Aer-O-Scope colonoscope system from GI-View, the manufacturer announced in early December.

“Aer-O-Scope provides reliable and safe colorectal cancer screening. It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer," Erwin Santo MD, head of the department of gastroenterology and liver diseases at Tel Aviv Sourasky Medical Center and principal investigator of the most recent Aer-O-Scope clinical trial, said in the press release. Read more 

FDA approved Somatuline Depot for gastroenteropancreatic neuroendocrine tumors

On December 16, the FDA approved lanreotide for treatment of patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The approval was based in part on results of a trial that included 204 patients with non-functioning gastroenteropancreatic neuroendocrine tumors. More than half of the patients (55%) had tumors that were outside of the pancreas. Read more