|
|
Article: FDA grants orphan drug status to pafuramidine for treatment of African sleeping sickness.(Industry News)
- Article from:
- Pharmaceutical Processing
- Article date:
- October 1, 2007
CopyrightCOPYRIGHT 2007 Advantage Business Media. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
Immtech Pharmaceuticals, Inc. has announced that the FDA has granted Orphan Drug Designation to pafuramidine (DB289) for treating Human African Trypanosomiasis (HAT), also known as African sleeping sickness. Orphan drug designation provides Immtech with numerous financial and regulatory benefits during pafuramidine's development, including government grants for conducting clinical trials, waiver of New Drug Application submission fees, tax credits, and a seven-year market exclusivity upon final FDA approval.
Pafuramidine is currently in phase III clinical trials for African sleeping sickness at six trial sites in Africa. The infectious disease, spread by tsetse ...