Neovacs announces FDA approval


Healio Rheumatology

May 2, 2016


Neovacs recently received FDA investigational new drug approval to extend its ongoing phase 2b clinical trial of the company’s anti-interferon alpha vaccine, IFNα Kinoid, for the treatment of lupus to the United States.

According to a company press release, the objective of the phase 2b trial is to evaluate the biological and clinical efficacy of the IFNα Kinoid vs. placebo. Full Phase 2b results of the worldwide multicenter study are expected in mid-2017.




“This clearance by the FDA is a success for Neovacs and will allow us to extend our actual trial to American investigators and patients,” Miguel Sieler,chief executive officer of Neovacs, said in the press release. “The FDA has given this approval within the regulatory time frame which demonstrates the complete and convincing character of our file. Important investigating centers, notably in New York, Oklahoma and Miami, have been waiting for this authorization to set up the trial. Therefore, the recruitment of patients will start soon.”