FDA approval of Ryplazim (plasminogen, human-tmvh) for treatment of plasminogen deficiency type 1 (hypoplasminogenemia)

Approval based on a single-arm, open-label clinical trial of 15 patients which demonstrated at least 50% improvement in lesions in all 11 patients who had lesions at baseline, and absence of recurrent or new lesions in any of the 15 patients through 48 weeks of treatment.

Source:

US Food and Drug Administration