Updated on 20 May 2013
US FDA approves Oramed Investigational New Drug Application (INDA) for its orally ingestible insulin capsule, ORMD-0801
Singapore: Israel-based Oramed Pharmaceuticals received approval from the US FDA for its Investigational New Drug Application (INDA) for ORMD-0801, its oral insulin capsule.
Oramed's ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite.
Orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream.
Dr Nadav Kidron, CEO, Oramed, said that, "We are very pleased to have the FDA clearance to proceed. The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801's clinical development in the US."