RedHill Biopharma announced that it has submitted a new drug application to the FDA for Talicia to treat H. pylori infection.
The company said in a news release that the NDA is supported by positive data from two phase 3 clinical trials, ERADICATE Hp and ERADICATE Hp2.
“Talicia demonstrated robust results in its clinical studies for H. pylori infection, a common and increasingly resistant and difficult to treat pathogen,” Ira Kalfus, MD, RedHill’s medical director, said in the release. “Importantly, in our clinical study, no H. pylori resistance to rifabutin, one of the key ingredients in Talicia, was identified pre- and post-treatment. We believe Talicia has the potential to become the new first-line, standard-of-care therapy for H. pylori infection.”
According to RedHill, Talicia is a novel, patent-protected and proprietary fixed-dose, all-in-one oral capsule for the treatment of H. pylori infection. Additionally, according to the release, the goal is for Talicia to address the increasing resistance of H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies.
“The NDA submission for talicia is a transformative milestone for RedHill and a critical step in our efforts to bring this much needed potential new therapy for H. pylori infection to the market,” Gilead Raday, chief operating officer at RedHill, said in the release. “Assuming FDA approval, commercial launch is planned for the fourth quarter of 2019 with our established U.S. sales force, led by a highly experienced commercial management team.”