Andromeda Biotech Ltd. announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for DiaPep277 for the treatment of type 1 diabetes (T1D) patients with residual beta cell function.
The designation of Orphan Drug status offers 7 years marketing exclusivity from the time of approval. In addition, this may present other benefits such as tax incentives, reduced user fees, and assistance for the registration process.
DiaPep277 is currently in Phase 3 clinical studies. A first study, which was conducted in Europe, South Africa, and Israel, met its primary endpoint based on initial results. A global confirmatory Phase 3 study is now being conducted in more than 120 medical centers.
Shlomo Dagan commented, “This is a significant milestone for the company giving us recognition and confidence following the long path in the development process. We believe in the potential of the product to benefit type 1 diabetes patients, thus providing incentive to pursue such a therapy to address the current clinical unmet need.”
Date: May 28, 2012
Source: Andromeda Biotech Ltd.