Neovacs, a leader in active immunotherapies for the treatment of autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted “Fast Track” status to IFN-alpha Kinoid in Lupus, the most advanced therapeutic vaccine issued from Neovacs R&D.
The FDA’s “Fast Track” designation is granted to therapies in development that target severe diseases or those that are life threatening and which have shown their ability to address an unmet medical need, based on clinical data.
This status facilitates exchanges with the FDA, accelerates the further product development and allows for a priority review of the product registration file. As a result of this designation, Neovacs has the best conditions to allow faster access to the IFN-alpha Kinoid for American patients.
