FDA News

7 recent FDA updates you may have missed

Healio Gastroenterology and Liver Disease has compiled a list of some of the most recent approvals and updates from the FDA.

Our readers were most interested in the approval of Ibsrela for IBS-C, a boxed warning for Xeljanz in ulcerative colitis, and a recommendation for manufacturers and health care facilities to switch to duodenoscopes with disposable components to reduce infection risk.

FDA approves Ibsrela for IBS-C in adults

The FDA recently approved Ibsrela, a 50 mg, twice-daily oral therapy for irritable bowel syndrome with constipation in adults.

“Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States,” Mike Raab, president and CEO of Ardelyx, said in a company-issued press release. READ MORE.

FDA urges move to duodenoscopes with disposable components

Because of the challenges associated with the reprocessing and cleaning of duodenoscopes with fixed endcaps, the FDA is recommending that manufacturers of the device and health care facilities transition to duodenoscopes with disposable components.

“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “This is why we’re communicating with health care facilities now — so they can begin developing a transition plan to replace conventional duodenoscopes — and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models.” READ MORE.

FDA revises draft guidance on clinical evaluation of gastroparesis drugs

The FDA has provided a revised version of the draft guidance on trial designs and endpoints for clinical evaluation of gastroparesis medication.

The updates concern the agency’s initial guidance on gastroparesis trials issued in July 2015. READ MORE.

FDA approves boxed warning for Xeljanz in UC

The FDA recently issued a safety alert and approved new Boxed Warning for the 10-mg, twice-daily dosage of tofacitinib in patients with ulcerative colitis; the warning comes after increased blood clot and death risks were seen in a rheumatoid arthritis trial.

Additionally, the FDA alert states that the approved use of tofacitinib (Xeljanz, Pfizer) for UC should be limited to specific patients who are not treated effectively or who experience severe side effects with certain other medicines. READ MORE.

FDA approves Keytruda for recurrent squamous cell carcinoma of the esophagus

The FDA approved pembrolizumab as monotherapy for certain patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus.

The approval applies to use of pembrolizumab (Keytruda, Merck) for patients whose tumors express PD-L1 — with a combined positive score of 10 or higher — as determined by an FDA-approved test, and who experienced disease progression after one or more previous lines of systemic therapy. READ MORE.

FDA grants breakthrough designation to liver cancer liquid biopsy test

The Laboratory for Advanced Medicine announced via a press release that the FDA granted breakthrough device designation to its liquid biopsy liver cancer detection test.

“The FDA’s recognition of the liquid biopsy test’s potential for the early detection of liver cancer represents a significant milestone for the company,” Shu Li, PhD, chairman and CEO of Laboratory for Advanced Medicine, said in the release. “The ability to accurately detect cancer from a blood draw holds immense promise for improving the diagnosis, prognosis and monitoring of cancer. Testing for and detecting cancer earlier, even before symptoms arise, enables physicians to treat earlier and smarter, improving patient chances of survival and reducing the cost associated with treatment.” READ MORE.

FDA warns about rare instances of liver injury, failure with HCV therapies

The FDA has received reports that the use of Mavyret, Zepatier or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver disease has resulted in rare cases of liver injury or liver failure, according to a drug safety communication.

“While FDA-approved treatments for HCV, including Mavyret, Zepatier and Vosevi, have been widely used for many years and are safe and effective ... [it’s] important for patients and health care professionals to recognize these drugs are not indicated for use in patients with moderate-to-severe liver impairment and that there are other effective FDA-approved treatment options available for those patients with those conditions,” Debra Birnkrant, MD, from the FDA’s Center for Drug Evaluation and Research, said in a press release. “Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective.” READ MORE.

Healio Gastroenterology and Liver Disease has compiled a list of some of the most recent approvals and updates from the FDA.

Our readers were most interested in the approval of Ibsrela for IBS-C, a boxed warning for Xeljanz in ulcerative colitis, and a recommendation for manufacturers and health care facilities to switch to duodenoscopes with disposable components to reduce infection risk.

FDA approves Ibsrela for IBS-C in adults

The FDA recently approved Ibsrela, a 50 mg, twice-daily oral therapy for irritable bowel syndrome with constipation in adults.

“Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States,” Mike Raab, president and CEO of Ardelyx, said in a company-issued press release. READ MORE.

FDA urges move to duodenoscopes with disposable components

Because of the challenges associated with the reprocessing and cleaning of duodenoscopes with fixed endcaps, the FDA is recommending that manufacturers of the device and health care facilities transition to duodenoscopes with disposable components.

“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “This is why we’re communicating with health care facilities now — so they can begin developing a transition plan to replace conventional duodenoscopes — and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models.” READ MORE.

FDA revises draft guidance on clinical evaluation of gastroparesis drugs

The FDA has provided a revised version of the draft guidance on trial designs and endpoints for clinical evaluation of gastroparesis medication.

The updates concern the agency’s initial guidance on gastroparesis trials issued in July 2015. READ MORE.

FDA approves boxed warning for Xeljanz in UC

The FDA recently issued a safety alert and approved new Boxed Warning for the 10-mg, twice-daily dosage of tofacitinib in patients with ulcerative colitis; the warning comes after increased blood clot and death risks were seen in a rheumatoid arthritis trial.

Additionally, the FDA alert states that the approved use of tofacitinib (Xeljanz, Pfizer) for UC should be limited to specific patients who are not treated effectively or who experience severe side effects with certain other medicines. READ MORE.

FDA approves Keytruda for recurrent squamous cell carcinoma of the esophagus

The FDA approved pembrolizumab as monotherapy for certain patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus.

The approval applies to use of pembrolizumab (Keytruda, Merck) for patients whose tumors express PD-L1 — with a combined positive score of 10 or higher — as determined by an FDA-approved test, and who experienced disease progression after one or more previous lines of systemic therapy. READ MORE.

FDA grants breakthrough designation to liver cancer liquid biopsy test

The Laboratory for Advanced Medicine announced via a press release that the FDA granted breakthrough device designation to its liquid biopsy liver cancer detection test.

“The FDA’s recognition of the liquid biopsy test’s potential for the early detection of liver cancer represents a significant milestone for the company,” Shu Li, PhD, chairman and CEO of Laboratory for Advanced Medicine, said in the release. “The ability to accurately detect cancer from a blood draw holds immense promise for improving the diagnosis, prognosis and monitoring of cancer. Testing for and detecting cancer earlier, even before symptoms arise, enables physicians to treat earlier and smarter, improving patient chances of survival and reducing the cost associated with treatment.” READ MORE.

FDA warns about rare instances of liver injury, failure with HCV therapies

The FDA has received reports that the use of Mavyret, Zepatier or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver disease has resulted in rare cases of liver injury or liver failure, according to a drug safety communication.

“While FDA-approved treatments for HCV, including Mavyret, Zepatier and Vosevi, have been widely used for many years and are safe and effective ... [it’s] important for patients and health care professionals to recognize these drugs are not indicated for use in patients with moderate-to-severe liver impairment and that there are other effective FDA-approved treatment options available for those patients with those conditions,” Debra Birnkrant, MD, from the FDA’s Center for Drug Evaluation and Research, said in a press release. “Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective.” READ MORE.

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