Delta-Fly Pharma, Inc. received orphan drug designation for DFP-10917 from the US Food and Drug Administration
8 December 2022
Delta-Fly Pharma, Inc. reports that the US Food and Drug Administration has received orphan drug designation for DFP-10917, a lead pipeline of the company of acute myeloid leukemia.
With the ODD, Delta-Fly Pharma, Inc. could claim a seven-year market exclusivity and some benefits such as research and development credits in view of regulatory approval.
DFP-10917 is an investigational anticancer compound for the treatment of patients with refractory/relapsed AML. A Phase 3 clinical trial is ongoing at the MD Anderson Cancer Center in Texas and other major sites for hematologic cancer therapies in the United States. The company expects the patient recruitment plan to be completed soon.
Delta-Fly Pharma, Inc. focuses not only on the cancer itself, but on the overall context factors of cancer patients and aims to provide medicines that are recommended for cancer patients and their families.
company profile
Company Name
Delta-Fly Pharma, Inc. [Tokyo:4598]
Capital
3352 million Japanese yen
Representative's name and title
Kiyoshi Eshima, PhD, President
Date of company incorporation
December 6, 2010
Description of business
Research and development, manufacturing and marketing of pharmaceuticals
corporate headquarters
37-5, Nishikino, Miyajima, Kawauchi-cho, Tokushima 771-0116, Japan
branches
Tokyo, Beijing, Vancouver
The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.
Contacts
Delta-Fly Pharma, Inc.
Inquiries: Yasuo Matsueda
Tel: +81-(0)3-6231-1278
ymatsueda1206@delta-flypharma.co.jp
https://www.delta-flypharma.co.jp/en/
Source:businesswire.com