FDA Grants Orphan Status to CTCL Drug


The U.S. Food and Drug Administration has granted orphan drug designation to Eisai Inc. for its investigational compound E7777 for cutaneous T-cell lymphoma (CTCL).

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

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 against CTCL.

About CTCL

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's lymphoma.

Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Its portfolio and focus includes oncology and specialty care, including Alzheimer's disease, epilepsy and metabolic disorders.

Source: Marketwatch

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