The FDA has granted orphan drug designation for Andromeda Biotech's DiaPep277 to treat type 1 diabetes (T1D) patients with residual beta cell function.
The orphan drug status offers seven years marketing exclusivity from the time of approval and provides benefits such as tax incentives, reduced user fees and assistance for the registration process.
Andromeda CEO Shlomo Dagan said, "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."
DiaPep277 is currently in Phase III clinical studies. A first study met its primary endpoint based on initial results.
A global confirmatory Phase III study is being conducted in more than 120 medical centers, the company said.
