FDA 2022 Rewind: GI drug pipeline rattles as FDA delivers 7 new drugs, 1 costly rejection
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Gastroenterology had a big year in 2022, with potentially game-changing FDA approvals for inflammatory bowel disease and several first-in-class therapies, yet the FDA’s rejection of the first hepatitis D therapy still looms large.
Over the past year, the FDA has greenlit several notable additions to the gastroenterology armamentarium, including the first treatment for eosinophilic esophagitis and the first approved fecal microbiota therapeutic, as well as well new gastrointestinal indications for two blockbuster biologics.
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Healio has closely followed these FDA decisions throughout the year, reporting on approvals that made major headlines as well as those that snuck in under the radar. Want to see what you missed? We have compiled a list of the FDA decisions from 2022 that will change the treatment paradigm in gastroenterology in 2023 and beyond.
FDA approves first treatment for eosinophilic esophagitis in the US
The FDA has granted approval for dupilumab for the treatment of eosinophilic esophagitis for adult and pediatric patients aged 12 years and older, according to a press release.
Dupilumab (Dupixent, Sanofi; Regeneron Pharmaceuticals, Inc.) is the first drug in the U.S. specifically indicated for the treatment of this condition.
“It is very exciting that we now have the first FDA-approved treatment option specifically for patients with eosinophilic esophagitis, and one that is targeted to an underlying cause of this disease,” Evan Dellon, MD, professor of medicine in the division gastroenterology and hepatology at the University of North Carolina School of Medicine, said. “Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications. Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease.” Read more.
FDA approves fecal microbiota biotherapeutic for recurrent C. difficile infection
The FDA has approved Rebyota, a microbiota-based live biotherapeutic indicated for the prevention of recurrent Clostridioides difficile infection in adults after antibiotic treatment, Ferring Pharmaceuticals announced in a press release.
The approval comes after an FDA panel voted in favor of Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) in September 2022, with the Vaccines and Related Biological Products Advisory Committee voting 13-4 in favor of the availability of adequate data supporting effectiveness and 12-4, with one abstention, in favor of the availability of adequate data supporting safety. Read more.
FDA approves Skyrizi for moderately to severely active Crohn’s disease
The FDA has approved AbbVie’s Skyrizi for the treatment of adults with moderately to severely active Crohn’s disease, according to a company press release.
Previously approved in the United States for the treatment of adult patients with moderately to severely active plaque psoriasis and psoriatic arthritis, Skyrizi (risankizumab-rzaa, AbbVie) is the first interleukin-23 inhibitor to enter the Crohn’s disease market. Read more.
FDA approves two vonoprazan treatment regimens for H. pylori infection
Phathom Pharmaceuticals Inc. has announced FDA approval for its Voquezna Triple and Dual Paks for the treatment of Helicobacter pylori infection in adults.
According to a press release, the new drug applications for Voquenza Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets; Phathom Pharmaceuticals) and Voquenza Dual Pak (vonoprazan tablets, amoxicillin capsules; Phathom Pharmaceuticals) were given priority review designation by the FDA after previous classification as qualified infectious disease products. Both regimens contain vonoprazan, an innovative potassium-competitive acid blocker, and are supplied in blister packs to promote compliance. Read more.
FDA rejects Gilead’s bulevirtide for hepatitis D, compensated liver disease
The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease.
In its letter, the FDA cited concerns over the manufacture and delivery of bulevirtide, a first-in-class investigational entry-inhibitor; however, no new studies to assess the safety and efficacy of the drug have been requested. Read more.
FDA approves Rinvoq for moderate to severe ulcerative colitis
Biopharmaceutical company AbbVie announced FDA approval for Rinvoq for the treatment of adults with moderately to severely active ulcerative colitis.
“This is a major development, as the degree of efficacy and the rapidity of response for [Rinvoq (upadacitinib, AbbVie)] are quite impressive,” Edward V. Loftus, Jr., MD, gastroenterologist at the Mayo Clinic in Rochester, Minnesota, and Healio Gastroenterology chief medical editor, told Healio. “It will be great to have another treatment option for our patients with ulcerative colitis.” Read more.
FDA approves Fresenius Kabi’s Idacio as eighth adalimumab biosimilar
The FDA has approved Idacio as the eighth biosimilar to adalimumab, for all eligible indications of the reference product, clearing the way for its U.S. release in 2023 alongside a deluge of other Humira biosimilars.
Idacio (adalimumab-aacf, Fresenius Kabi) is a citrate-free biosimilar to the world’s top-selling Humira (adalimumab, AbbVie), a TNF inhibitor approved to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Read more.
FDA approves Konvomep for benign gastric ulcers, risk reduction for upper GI bleeding
The FDA has approved an oral suspension omeprazole and sodium bicarbonate for the treatment of active benign gastric ulcer and to reduce risk for upper gastrointestinal bleeding, according to an Azurity Pharmaceuticals press release.
With this approval, Konvomep – consisting of 2 mg omeprazole and 84 mg sodium bicarbonate per mL after reconstitution – is indicated as a short-term treatment (40 mg once daily for 4-8 weeks) for adults with benign gastric ulcers. It is also indicated as risk reduction for upper GI bleeding in critically ill adult patients, with an initial dosage of 40 mg followed by 40 mg 6-8 hours later and 40 mg once daily for 14 days. Read more.