Coversin by Akari therapeutics receives Orphan drug Designation from FDA

Release Date: 06-Oct-2016

Coversin developed by Akari therapeutics, an emerging pharmaceuticals company dedicated to the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases has been granted orphan drug designation for the treatment of Paroxysmal Nocturnal Hemoglobinuria.


PNH is an ultra-rare, life-threatening and debilitating disease of the blood with estimated 8,000-10,000 patients across North America and Europe. The PNH patients suffer from a certain genetic deficiency in which they allow their own complement system to attack and destroy blood cells, leading to life-threatening complications.


According to FDA, orphan drug designation status is given to those drugs or treatments which promise to cure or prevent rare life threatening diseases. By FDA, rare diseases are defined as those which affect less than 200,000 people in US. Also, FDA helps the companies which cultivate such drugs by providing them with incentives to sponsor developing drugs and biologics. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval and designation does not mean that marketing approval will be received.


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