FDA grants orphan drug status to Senesco multiple myeloma drug

The orphan drug status allows Senesco to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval, allowance for marketing exclusivity after drug approval for a period of as long as seven years and potential exemption from the FDA’s prescription drug application fee.

Senesco CEO Leslie Browne said that as the FDA has granted orphan drug status for their lead therapeutic candidate SNS01-T as they prepare to begin clinical studies in multiple myeloma.

"Orphan drug designation can provide us with significant regulatory and financial advantages to move our candidate forward in clinical trials," Browne said.

"We believe that the tumor growth inhibition observed during preclinical studies is promising and that orphan drug status could allow Senesco to accelerate clinical development and hopefully make this therapy available to patients sooner."