FDA Grants Orphan Drug Status To Eisai's Lenvatinib

WOODCLIFF LAKE, N.J., Feb. 14, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.

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The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

Lenvatinib, discovered and developed by Eisai, is an investigational small molecule tyrosine kinase inhibitor being studied globally as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC).

About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs between the ages of 25 and 65.

The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 95 percent of all cases.  While most of these are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and resistant form of thyroid cancer.

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which is to help address unmet medical needs and to increase the benefits health care provides to patients and their families. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications.

Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. 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 www.eisai.com/US.

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.

SOURCE Eisai Inc.