RedHill Biopharma announced that the FDA has accepted a new drug application for its Helicobacter pylori infection therapy, Talicia.
Additionally, the NDA for Talicia (RHB-105) has been granted priority review by the FDA and was assigned a Prescription Drug User Act action date of sometime in November, according to a company press release.
“The efficacy of current standard-of-care therapies for H. pylori bacterial infection continues to decline due to the high and steadily increasing prevalence of antibiotic-resistant strains. This public health concern is widely recognized by the U.S. government and other leading health agencies, including the World Health Organization, which classified H. pylori as a Group
I carcinogen and highlighted the urgent need for new treatments for H. pylori eradication,” Dror Ben-Asher, RedHill CEO, said in the release. “The acceptance for review of the NDA for Talicia and the priority review designation are encouraging steps as we continue our intensive preparations for a potential U.S. commercial launch of Talicia as a new first-line, standard-of-care therapy for H. pylori. We continue to work closely with the FDA, with the aim of bringing this important new therapy to patients.”
Commercial launch, according to the release, would begin shortly following a possible FDA approval.