FDA Adds Three Months To Review Of Takeda's New Drug Application

Takeda Pharmaceutical Company Limited ("Takeda") recently announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification from the U.S. Food and Drug Administration (FDA) that the agency will not be able to complete its review of the TAK-390MR New Drug Application (NDA) by the original Prescription Drug User Fee Act (PDUFA) date in October, 2008.

"The FDA informed Takeda that it will require an additional three months to complete the review of the TAK-390MR NDA," said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. "Takeda has been very responsive to all questions posed during the review cycle. Such dialogue between a sponsor company and the FDA is common during the review of any NDA. The FDA needs this time to review the total package of information contained in the NDA. Takeda will continue to work with the FDA for completion of the review by the revised date. Takeda is confident TAK- 390MR will be an important new treatment option for people living with GERD and erosive esophagitis."

TAK-390MR, an investigational compound, is currently under review with the U.S. Food and Drug Administration (FDA) for once-daily, oral treatment of daytime and nighttime heartburn and other symptoms of Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed erosive esophagitis. The New Drug Application (NDA) for TAK-390MR, submitted in December 2007, was based on global studies conducted in 20 countries, in approximately 6,000 patients with erosive and non-erosive GERD.

SOURCE: Takeda Pharmaceutical Company Limited