RedHill Biopharma Receives FDA Acceptance for New Drug Application of Talicia

RedHill Biopharma (NASDAQ:RDHL) has announced that the US Food and Drug Administration (FDA) has accepted its Talicia new drug application for review.

As quoted in the press release:

The NDA for Talicia has also been granted Priority Review designation and was assigned a target Prescription Drug User Act (PDUFA) action date by the FDA of November 2, 2019.

Priority Review is a designation granted by the FDA to prioritize the review process for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions when compared to standard applications.

Commercial launch of Talicia with RedHill’s existing U.S. sales force is planned shortly following potential FDA approval.

If approved, Talicia would be eligible for a total of eight years of U.S. market exclusivity.

H. pylori bacterial infection affects more than 50% of the population worldwide² and approximately 35% of the U.S. population³. It is classified as a Group I carcinogen and is the strongest risk factor for the development of gastric cancer² and a major risk factor for peptic ulcer disease⁴ and gastric mucosa-associated lymphoid tissue (MALT) lymphoma⁵. H. pylori-infected persons have a 6-fold increased risk of developing non-cardia gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma⁴.

Click here to read the full press release.