DuoCort gets EU orphan drug designation
- Details
- Published on Monday, 29 May 2006 09:41
DuoCort AB has been granted an Orphan Medicinal Product Designation for its new hydrocortisone dual-release oral tablet for the treatment of adrenal insufficiency. Orphan drug designation gives DuoCort access to regulatory assistance from the European Medicines Agency (EMEA) during the development phase, reduced filing fees, and market exclusivity in the EU for ten years after the product attains marketing authorization.
“Orphan designation is of great value top the company
and gives us access to important regulatory assistance which will
greatly facilitate the development of this improved therapy for the
life-long treatment of patients with chronic adrenal insufficiency,”
said Dr. Stanko Skrtic, MD, PhD, Vice President of Regulatory Affairs
at DuoCort.
The orphan-designated product is a novel, modified release, oral
hydrocortisone tablet for patients with chronic adrenal insufficiency,
a rare disease which affects an estimated 125,000 patients in the
European Union.
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