You are here
Orphan Drug Status Granted to Icatibant
"We are pleased to receive the FDA's orphan drug designation for Icatibant in a second indication," said Jens Schneider-Mergener, Chief Executive Officer of Jerini. "The orphan drug designation is an important component of our development and commercialization strategy."
The FDA grants orphan drug designation to drugs that provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug status provides for U.S. marketing exclusivity for seven years upon marketing approval by the FDA. Additionally the designation qualifies a product for possible funding to support clinical trials, study design assistance from the FDA during development and for financial incentives.
Source: Jerini AG