The FDA approved Talicia for the treatment of Helicobacter pylori infection in adults, manufacturer Redhill Biopharma announced.
H. pylori infection is the major cause of peptic ulcers and gastritis and is associated with an up to six-fold increased risk for gastric cancer and mucosal associated-lymphoid-type lymphoma, according to the CDC.
Redhill said Talicia (omeprazole magnesium, amoxicillin and rifabutin) is the first and only FDA-approved rifabutin-based H. pylori therapy and is designed to address the “high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy,” which is estimated to have more than doubled between 2009-2013.
“Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade,” Colin W. Howden, MD, Hyman Professor of Medicine and chief of the division of gastroenterology at the University of Tennessee Health Science Center, said in a news release. “Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”
Researchers evaluated the drug in a phase 3 study in patients with confirmed H. pylori infection. Participants received four capsules of either Talicia or the active comparator three times daily for 14 days. The trial, known as ERADICATE Hp2, demonstrated 84% eradication of H. pylori infection with Talicia compared with 58% in the active comparator arm in the intent to treat population.
The FDA had accepted a new drug application for Talicia and granted it priority review in July. Redhill said the commercial launch date, which is expected for the first quarter of 2020, will be announced in a live webcast on Nov. 22.
“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases,” Redhill CEO Dror Ben-Asher said in the release. “We are working to expand our sales force to approximately 140 representatives who will promote Talicia, [Aemcolo (rifamycin, Cosmo Pharmaceuticals)] and other gastrointestinal-focused products in our basket.” – by Caitlyn Stulpin
Disclosures: Ben-Asher is an employee of RedHill Biopharma. Howden reports no relevant financial disclosures.