FDA gains steam in 2023: GI pipeline boasts numerous milestones, 2 crucial setbacks

The first half of 2023 has already seen landmark FDA decisions in the gastroenterology space, including multiple first-in-class therapies along with two costly rejections that highlight persistent gaps in the GI drug armory.

Since April, the agency has approved several firsts in the GI field, including the first drug to treat functional constipation in children, the first oral microbiota biotherapeutic for recurrent C. difficile and the first oral product to treat moderately to severely active Crohn’s disease.

The FDA also greenlit colonoscopy prep flavored like a “lemon-lime” sports drink, a generic version of a rectal foam for inducing remission of mild to moderate ulcerative colitis, and more.

Healio has closely followed these FDA decisions, reporting on long awaited approvals as well as those that came as a surprise. In case you missed any of it, Healio has compiled the FDA’s latest gastroenterology news below.

FDA approves Vowst as first oral microbiota biotherapeutic for recurrent C. difficile

The FDA has approved Vowst, the first orally administered fecal microbiota product indicated for the prevention of recurrent Clostridioides difficile infection in adults following antibacterial treatment.

With this approval, Vowst (SER-109, Seres Therapeutics) becomes the second microbiota-based live biotherapeutic approved for recurrent C. difficile infection following the approval of Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) in 2022. Read more.

Intercept pivots away from NASH following second FDA rejection for obeticholic acid

The FDA issued a complete response letter to Intercept indicating it cannot approve the company’s new drug application for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.

Following an unfavorable vote before the FDA’s Gastrointestinal Drug Advisory Committee in May, the agency’s rejection of obeticholic acid (Ocaliva, Intercept Pharmaceuticals) was not unexpected. In its letter, the FDA emphasized that any resubmission of obeticholic acid (OCA) for NASH would require at least successful completion of long-term patient outcomes data from the REGENERATE study. Read more.

FDA grants fast track designation to Merck’s efinopegdutide for treatment of NASH

The FDA granted fast track designation to efinopegdutide for the treatment of nonalcoholic steatohepatitis, according to a manufacturer’s press release.

Efinopegdutide (MK-6024, Merk), an investigational peptide and dual agonist at glucagon-like peptide 1 (GLP-1) and glucagon receptors, is being developed under a licensing agreement between Merck and Hanmi Pharmaceutical. Read more.

FDA approves Rinvoq as first oral therapy for moderate to severe Crohn’s disease

The FDA has approved AbbVie’s Rinvoq as a once-day pill intended for the treatment of adult patients with moderate to severe Crohn’s disease who are intolerant, or have had an inadequate response, to one or more TNF inhibitors.

Upadacitinib (Rinvoq, AbbVie) is now indicated for both Crohn’s disease and ulcerative colitis. Additionally, this decision marks the drug’s seventh FDA approval across gastroenterology, dermatology and rheumatology. Read more.

FDA approves Linzess as first treatment for pediatric functional constipation

The FDA has approved Linzess, the first therapy for pediatric functional constipation in patients aged 6 to 17 years, according to an agency release.

The supplemental new drug application for Linzess (linaclotide 72 µcg, AbbVie/Ironwood), which was previously approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation, was assigned an early Prescription Drug User Fee Act date of June 14, approximately 4 months earlier than would be assigned in the standard review cycle. Read more.

FDA rejects Eli Lilly’s mirikizumab for ulcerative colitis, citing manufacturing concerns

The FDA issued a complete response letter to Eli Lilly indicating it cannot approve the company’s biologic license application seeking approval for mirikizumab as a treatment for ulcerative colitis.

In its letter, the FDA cited concerns over the proposed manufacturing of mirikizumab, a first-in-class monoclonal antibody selectively targeting the IL-23 p19 subunit; however, the agency reported no issues regarding the clinical data package, safety or label for the drug. Read more.

FDA approves Bylvay for cholestatic pruritus due to Alagille syndrome

The FDA has approved Bylvay for the treatment of cholestatic pruritus due to Alagille syndrome in patients aged 12 months or older, according to an Ipsen Biopharmaceuticals press release.

This approval marks the second rare cholestatic liver disease indication for Bylvay (odevixibat, Ipsen/Albiero Pharmaceuticals), a non-systemic ileal bile acid transport inhibitor originally approved in 2021 for pruritus in all subtypes of progressive familial intrahepatic cholestasis. Read more.

FDA approves Padagis’ generic budesonide rectal foam for ulcerative colitis

Padagis received FDA approval of its abbreviated new drug application for budesonide 2mg rectal foam for the induction of remission in patients with mild to moderate ulcerative colitis, according to a manufacturer release.

The FDA has also designated Padagis’ product as a competitive generic therapy, which effectively prevents approval of other ANDAs for this indication for a period of 180 days. Read more.

FDA grants 510(k) clearance to Olympus’ EVIS X1 endoscopy system, compatible endoscopes

The FDA granted 510(k) clearance to Olympus Medical for its EVIS X1 endoscopy system and two compatible gastrointestinal endoscopes, according to a manufacturer press release.

This clearance encompasses Olympus’ EVIS X1 system, as well as its accompanying GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope for use in the lower digestive tract. Read more.

FDA approves Suflave, Sebela’s low-volume, ‘lemon-lime’ flavored colonoscopy prep

The FDA has approved Suflave, an osmotic laxative consisting of polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate and sodium chloride, for colonoscopy preparation in adults, according to the manufacturer.

Sebela Pharmaceuticals noted that patient tolerance for bowel preparation remains a significant deterrent for those considering screening colonoscopy, with most patients citing colonoscopy prep as the worst aspect “due to large volumes of poor-tasting solutions.” Intended to reduce prep hesitancy and improve patient compliance, the Suflave product offers a low-volume colonoscopy prep with “a taste similar to a lemon-lime” sports drink. Read more.