FDA Grants Orphan Drug Status To Eisai's Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma

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 non-Hodgkin lymphoma.

Eisai Inc.
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 healthcare system.

Media Inquiries

Investor Inquiries

Laurie Landau

Alex Scott

Eisai Inc.

Eisai Inc.

201-746-2510

201-746-2177

SOURCE Eisai Inc.

Type Press Release

Date Released August 08, 2013

RECENT RELEASES
Apr 16, 2021

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today that data from the company's deep neurology pipeline and portfolio, including Alzheimer's disease, insomnia and...

Apr 11, 2021

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that its animation “Leave No One Behind-Disease of Neglected People” which features activities for the...

Mar 31, 2021

Eisai Inc. announced today the launch of Spot Her—an initiative to end the silence around endometrial cancer, a type of uterine cancer, and inspire women to listen, advocate and put their health...

Alerts - Release page
SUBSCRIBE TO OUR NEWS
* Required Fields