Kedrion’s manufacturing facility in Bolognana, Italy, has been approved by US Food and Drug Administration (FDA) for the production of Ryplazim®, a plasma-derived human Plasminogen indicated for treating patients with Plasminogen Deficiency type 1 (PLGD-1).
Patients affected by this disease may require lifelong treatment.
“The FDA’s approval of our Bolognana facility is a pivotal moment for our company as we will be able to provide this treatment to more patients,” said Bob Rossilli, Kedrion Chief Commercial Officer, “and I want to thank all employees worldwide who contributed to this achievement”.
This accomplishment highlights Kedrion’s dedication to expanding access to life-enhancing therapies to patients with rare and ultra-rare diseases globally.