After July surge, FDA approvals for GI settle into summer lull: What you may have missed

Following a July boom in game-changing FDA approvals for gastroenterology, including the first blood test for colorectal cancer, the agency has succumbed to the summer lull with only three approvals for GI to close out the season.

Within the last few months, the FDA has approved several notable firsts for GI and liver disease care, including AbbVie’s Skyrizi (risankizumab) as the first IL-23 inhibitor approved for both ulcerative colitis and Crohn’s disease, and the first rapid test for hepatitis C virus intended for use in point-of-care settings.

The agency also greenlit a third ustekinumab biosimilar the interchangeable Pyzchiva (ustekinumab-ttwe; Samsung Bioepis, Sandoz) for the treatment of UC and Crohn’s as well as multiple other inflammatory conditions.

Healio has closely followed these FDA decisions throughout the summer, reporting on approvals that broke major headlines as well as those that snuck in under the radar. Want to see what you missed? We tallied up the FDA decisions expected to change the treatment paradigm for gastroenterology and hepatology in 2024 and beyond.

‘Tremendous leap forward’: FDA approves first colorectal cancer blood test

The FDA has approved Guardant Health’s Shield blood test to screen for colorectal cancer in patients aged 45 years and older at average risk for disease, according to a company press release.

With this approval, Shield is the first blood test to be approved as a primary screening option for colorectal cancer in line with other noninvasive screening options, and the first blood test to meet the performance requirements to be covered under Medicare, the company noted. Read more.

FDA approves Gilead’s Livdelzi for treatment of primary biliary cholangitis

Gilead’s Livdelzi, a selective peroxisome proliferator-activated receptor delta agonist, has received accelerated FDA approval for the treatment of primary biliary cholangitis, according to a company release.

Livdelzi (seladelpar) was approved for use in combination with ursodeoxycholic acid (UDCA) in adult patients who did not adequately respond to UDCA or as monotherapy for those who are intolerant to UDCA. Read more.

Skyrizi snags FDA approval for moderate to severe UC; first IL-23 approved for UC, CD

The FDA has approved Skyrizi for the treatment of adult patients with moderate to severe ulcerative colitis, making it the first interleukin-23 specific inhibitor approved for both UC and Crohn’s disease, AbbVie reported.

Skyrizi (risankizumab, AbbVie) is now approved for four indications across immune-mediated inflammatory diseases, including IBD, plaque psoriasis and psoriatic arthritis, according to a company press release. Read more.

FDA clears first ‘rapid diagnostic’ hepatitis C RNA test for point-of-care settings

The FDA granted marketing authorization for Cepheid’s Xpert HCV test and GeneXpert Xpress System, the first rapid test for hepatitis C virus intended for use in point-of-care settings.

According to the agency, the test detects HCV RNA using a fingertip blood sample, allowing results to be delivered within 1 hour. The FDA’s authorization “enables a test-and-treat approach,” in which an at-risk individual can be tested for HCV – and if positive – be linked to appropriate care, and possibly receive treatment, during the same health care visit. Read more.

Plozasiran secures FDA breakthrough status for FCS, closing gap with rival olezarsen

The FDA has granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, coupled with diet, to decrease triglycerides in patients with familial chylomicronemia syndrome, according to a company release.

A rare genetic hyperlipidemia, familial chylomicronemia syndrome (FCS) is characterized by extremely elevated triglyceride levels, which can increase risk for acute and potentially fatal pancreatitis, abdominal pain, diabetes and hepatic steatosis. A first-in-class investigational RNA interference therapeutic, plozasiran is intended to inhibit the production of apolipoprotein C-III, which will in turn reduce triglycerides and return lipids to normal levels. Read more.

Tremfya nabs FDA approval for active ulcerative colitis, chasing competitor Skyrizi

The FDA has approved Johnson & Johnson’s Tremfya, a dual acting interleukin-23 inhibitor, for the treatment of patients with moderately to severely active ulcerative colitis, according to a company release.

Tremfya (guselkumab) is now approved for three indications including plaque psoriasis, active psoriatic arthritis and UC, according to a company press release. With this approval, Tremfya is the latest contender in an increasingly crowded UC market alongside AbbVie and its rival IL-23 inhibitor, Skyrizi (risankizumab), which was approved for both Crohn’s disease and UC in June. Read more.

FDA expands Livmarli approval for pruritus in PFIC to infants as young as 12 months

The FDA has updated the label indication for Livmarli for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis, expanding the patient population to include infants aged 12 months and older.

This label expansion includes approval for a higher concentration formula of Livmarli (maralixibat, Mirum Pharmaceutical), a once-daily, ileal bile acid transporter, which was only approved earlier this year for patients aged 5 years or older with pruritus and PFIC. Read more.

FDA expands Voquezna approval for heartburn relief in non-erosive GERD

The FDA has expanded approval for Phathom Pharmaceuticals’ Voquezna tablets 10 mg to alleviate heartburn related in non-erosive gastroesophageal reflux disease, according to a company press release.

This is the third approved indication for Voquezna (vonoprazan) following FDA approvals in 2023 for the treatment of all severities of erosive esophagitis and Helicobacter pylori infection when combined with antibiotics. Read more.

FDA approves biosimilar Pyzchiva for all approved Stelara indications

The FDA has approved the Stelara biosimilar Pyzchiva for psoriatic arthritis, Crohn’s disease and all other indications approved for the reference medicine, according to a press release from Sandoz.

Pyzchiva (ustekinumab-ttwe; Samsung Bioepis, Sandoz) is slated to debut on the U.S. marketplace in February, according to the release. The Stelara (ustekinumab, Janssen) biosimilar, which has received interchangeable designation, was developed by Samsung Bioepis and licensed for marketing by Sandoz. Read more.

FDA grants orphan drug designation to pouchitis treatment derived from green tea

The FDA has granted orphan drug designation to PharmassêtX’s PSX-514, a drug derived from an active component of green tea, for the treatment of pouchitis, according to a company press release.

Currently, there is no approved treatment for pouchitis, a rare complication for patients with ulcerative colitis who undergo ileal pouch-anal anastomosis – or J-pouch procedure. PharmassêtX has been developing epigallocatechin gallate (EGCG), the main ingredient in green tea, to create a “high-purity, high-potency drug for the treatment of inflammatory bowel disease.” Read more.