Eisai announced today that the company received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.
The FDA issues a Complete Response Letter to indicate that the review cycle of an application is complete and the application is not ready for approval. Eisai will work with the FDA to address the requirements of the Complete Response Letter for the approval of rabeprazole sodium extended-release capsules, 50 mg.
Rabeprazole sodium extended-release capsules, 50 mg, is being evaluated as a new formulation that combines two different drug releasing mechanisms in one capsule to treat patients with GERD. An estimated 19 million Americans have GERD, commonly known as acid reflux disease, which is a medical condition characterized by persistent, frequent heartburn and regurgitation due to reflux of stomach acid into the esophagus. Some patients develop erosive GERD, in which there are breaks in the lining of the esophagus, the passage that connects the mouth to the stomach.
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