Eisai receives CRL for GERD drug

February 2, 2011

FDA has issued a complete response letter to Eisai for its 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 GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.

FDA has issued a complete response letter to Eisai for its 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 nonerosive GERD.

Details of FDA’s CRL to Eisai were not discussed in the company statement; however, Eisai stated it will work with FDA to address the requirements of the CRL for the approval of the new PPI.

Rabeprazole sodium extended-release capsules, 50 mg, are being evaluated as a new formulation that combines 2 different drug-releasing mechanisms in 1 capsule to treat patients with GERD. An estimated 19 million Americans have GERD.

“While it is presently unclear as to the nature of FDA’s complete response letter in this instance, with several highly safe and effective generic options available within the PPI category, the implications of this non-approval from a managed care perspective are likely quite limited at this time,” said David Calabrese, RPh, MHP, chief clinical officer, Med Metrics Health Partners, Worcester, Mass., and clinical editor of Formulary, Drug Topics' sister publication.