AstraZeneca submits Nexium sNDA for peptic ulcer bleeding

Anglo-Swedish drug major AstraZeneca has submitted a supplemental New Drug Application to the US Food and Drug Administration for Nexium IV (esomeprazole sodium) for Injection to seek approval for use in patients with peptic ulcer bleeding following therapeutic endoscopy.

The regulatory submission incorporates data from the Nexium IV Peptic Ulcer Bleed study, a multinational, randomized trial of 767 patients with the condition. To date, there is no proton pump inhibitor therapy globally approved for this indication. Presently, the AstraZeneca drug is indicated for the short-term treatment (up to 10 days) of gastro-esophageal reflux disease adult patients with a history of erosive esophagitis, as an alternative to oral therapy in patients when treatment with Nexium (esomeprazole magnesium) Delayed-Release Capsules is not possible or appropriate.