Delta-Fly Pharma, Inc. is granted Orphan Drug Designation by US Food and Drug Administration for DFP-10917
TOKUSHIMA, Japan, December 07, 2022--(BUSINESS WIRE)--Delta-Fly Pharma, Inc. announces that DFP-10917, a leading pipeline of the company, is granted Orphan Drug Designation (ODD) by US Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML).
Be given to ODD, Delta-Fly Pharma, Inc. can be entitled to seven extra years of marketing exclusivity and receive some benefits such as R&D rebate by getting approval.
DFP-10917 is an anti-cancer agent in development for the treatment of patients with Refractory/Relapsed AML. A Phase 3 clinical study has been underway at MD Anderson Cancer Center in Texas and other major sites of Hematologic Cancer Treatment in USA. The company expects to complete the patients’ enrollment plan soon.
Delta-Fly Pharma, Inc. focuses not only on cancer itself but on the whole conditions of cancer patients, and aims to deliver medicines that are recommendable for cancer patients and their families.
Delta-Fly Pharma, Inc. [Tokyo:4598]
3352 million Japanese Yen
Name and Title of Representative
Kiyoshi Eshima, PhD, President
Date of Incorporation
December 6, 2010
Description of Business
Research and development, manufacturing and marketing of pharmaceuticals
37-5, Nishikino, Miyajima, Kawauchi-cho, Tokushima 771-0116, Japan
Tokyo, Beijing, Vancouver
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Delta-Fly Pharma, Inc.
Inquiries: Yasuo Matsueda