The U.S. Food and Drug Administration (FDA) has granted “Fast Track” status to French biopharmaceutical company Neovacs’s IFNalpha Kinoid in Lupus, the most advanced therapeutic vaccine issued from Neovacs R&D.
Neovacs explained on Friday in a press release that 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 IFNalpha Kinoid for American patients, Neovacs said.
Neovacs is currently enrolling patients in an international Phase IIb trial (IFN-K 002) in Lupus (SLE), an autoimmune disease that is chronic and very invalidating and for which current treatments do not offer a satisfying therapy. The objective of this trial is to measure biological and clinical efficacy in moderate to severe SLE patients. This study, which has already recruited more than half of its targeted 178 patients, is underway in 21 countries in Europe, Asia, Latin America and the United States.
Miguel Sieler, CEO of Neovacs, said: “This announcement follows the IND obtained in April this year. It is the second favourable notification by the FDA to Neovacs in the course of 2016. We are proud to receive once again from the FDA the confirmation of the innovative character of our therapeutic approach.”
Dr. Therese Croughs, CMO of Neovacs, said: “This “Fast Track” designation reinforces our confidence in the therapeutic potential of IFN Kinoid as a treatment for Lupus. Today, the available treatments only aim to reduce the inflammation, to alleviate the symptoms and are associated with significant side effects.”