Posted by Michael Wonder on 03 Jun 2021
Protagonist Therapeutics receives FDA breakthrough therapy designation for rusfertide in polycythemia vera
3 June 2021 - Designation further validates registrational path for rusfertide in polycythemia vera and facilitates potentially expedited development and review.
Protagonist Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for its lead investigational new drug candidate, rusfertide, for the treatment of patients with polycythemia vera for the reduction of erythrocytosis in those patients who do not require further treatment for thrombocytosis and/or leukocytosis.
