WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eisai announced today that the United States Food and Drug Administration (FDA) issued a Complete Response Letter to Teikoku Pharma USA, Inc., regarding the New Drug Application (NDA) of the Aricept® Patch (donepezil transdermal system). The Aricept Patch was developed by Teikoku Pharma USA, Inc, a subsidiary of Teikoku Seiyaku Co., Ltd. Teikoku Pharma USA, Inc. and Eisai were seeking approval of the weekly Aricept Patch for the treatment of mild, moderate and severe stages of Alzheimer’s disease.
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 Teikoku Pharma USA to assess the Complete Response Letter and determine next steps. Eisai holds the marketing rights in the United States and will co-promote the Aricept Patch with Pfizer if approved.
The Aricept Patch is a weekly transdermal patch that was developed to provide an alternative formulation for Alzheimer’s patients. Eisai has a long-standing commitment to the treatment of Alzheimer’s disease and is dedicated to supporting the Alzheimer’s disease community.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit http://us.eisai.com.
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.
Marcia Diljak, 201-746-2236
Alex Scott, 201-746-2177