The US Food and Drug Administration (FDA) has granted orphan drug designation to Eisai Inc.'s 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., gives first thought to patients and their families, and helping to increase the benefits health care provides. The main goal is human health care.

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.