Top 7 in FDA news: Approvals for diarrhea relief, endoscopic devices, Crohn’s treatment
Click Here to Manage Email Alerts
Healio presents the following collection of FDA news related to gastroenterology, including the approval of generic diarrhea relief tablets, treatment for acid sphingomyelinase deficiency and biliary tract cancer, and more.
FDA approves Granules India Limited’s generic diarrhea relief tablets
Granules India Limited received FDA approval of its abbreviated new drug application for loperamide hydrochloride and simethicone tablets indicated for diarrhea symptom relief, according to a press release.
The FDA determined that, among adult patients with symptoms of diarrhea, bloating, pressure and cramps, Granules India’s loperamide hydrochloride and simethicone (2 mg/125 mg) product is therapeutically equivalent to Johnson & Johnson’s Imodium Multi-Symptoms Relief Tablets (2 mg/125 mg), which was used as a reference product. Read more.
FDA approves Xenpozyme, first treatment for rare acid sphingomyelinase deficiency
The FDA has approved Xenpozyme as the first treatment for patients with acid sphingomyelinase deficiency with symptoms unrelated to the central nervous system.
Acid sphingomyelinase deficiency (ASMD) is a rare condition caused by the lack of an enzyme necessary to break down a complex lipid — sphingomyelin — which collects in the liver, spleen, lung and brain. Patients with ASMD often have enlarged abdomens that can cause pain, vomiting, feeding difficulties and increased risk for falls, as well as accompanying abnormal liver and blood tests. Read more.
Humira biosimilar approval paused after FDA finds ‘deficiencies’ at manufacturing facility
The FDA approval of Alvotech’s Humira biosimilar is on hold until the company can address “certain deficiencies” the administration found during an inspection of a manufacturing facility, according to a press release.
A statement released by the company said it had received a message from the FDA detailing the administration’s March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland. According to the statement, the FDA noted “certain deficiencies” during that inspection as part of its complete response letter to Alvotech’s initial biologics license application (BLA) for its adalimumab (Humira, AbbVie) biosimilar AVT02. The letter added that a satisfactory resolution to these deficiencies would be required before the FDA may approve the application for AVT02. Read more.
FDA approves Imfinzi plus chemotherapy for advanced biliary tract cancer
The FDA approved durvalumab with gemcitabine and cisplatin for adults with locally advanced or metastatic biliary tract cancer.
Durvalumab (Imfinzi, AstraZeneca) — a PD-L1 checkpoint inhibitor — is approved in the United States for treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed after chemoradiotherapy. It also is approved for treatment of extensive-stage small cell lung cancer. Read more.
FDA approves citrate-free, high concentration formulation of Humira biosimilar
The FDA has approved a citrate-free, 100 mg/mL formulation of the Humira biosimilar Hadlima, according to a statement released by Samsung Bioepis and Organon.
“With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases,” Byoungin Jung, vice president and regulatory affairs team leader for Samsung Bioepis, said in the statement. “By leveraging our development expertise, manufacturing excellence and supply chain reliability, we will continue our work to ensure healthcare systems have more affordable treatment options available.” Read more.
FDA grants de novo clearance for endoscopic sleeve gastroplasty, bariatric revision devices
The FDA has granted de novo authorization for Apollo Endosurgery to market its Apollo ESG and Apollo REVISE endoscopic systems for the treatment of patients with obesity, according to a company press release.
These are the first devices authorized by the FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision procedures. 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.