FDA Grants Orphan Drug Status To Eisai's Investigational Compound (E7777) For
Cutaneous T-Cell Lymphoma
WOODCLIFF LAKE, N.J., Aug. 8, 2013
WOODCLIFF LAKE, N.J., Aug. 8, 2013 /PRNewswire/ --Eisai Inc. announced today
that the U.S. Food and Drug Administration (FDA) has granted orphan drug
designation to its investigational compound (E7777) for cutaneous t-cell
lymphoma (CTCL). E7777 is designed to have an improved purity profile and
manufacturing process. It is currently in a pivotal trial intended to support
its submission for approval.
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.
CTCL is a rare type of cancer that begins in the white blood cells and attacks
the skin. It is one of several types of lymphoma collectively called
At Eisai Inc., human health care is our goal. We give our first thoughts to
patients and their families, and helping to increase the benefits health care
provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co.,
Ltd., our passionate commitment to patient care is the driving force behind
our efforts to help address unmet medical needs. We are a fully integrated
pharmaceutical business with discovery, clinical, manufacturing and marketing
capabilities. Our key areas of commercial focus include oncology and specialty
care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more
about Eisai Inc., please visit us at 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
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