Shots:

• The P-III trial evaluates the efficacy and safety of GC5107 (IV- every 21 or 28 days for 12 mos.) in 49 patients aged 3-70yrs. with PI. The trial was conducted at 17 study sites (10 in the US & 7 in Canada)
• The trial met its1EP & 2EPs i.e.- <1 aSBI occurred among the patients during 1yr.- <40% showed temporally associated AEs within 72hrs. after infusion- >98% of the infusions were completed without discontinuation. GC5107 (10% IgG formulation) is safe- effective- and well-tolerated in adolescent and adult patients
• In Feb’21- the company had submitted a BLA to the US FDA based on the clinical trial results. The anticipated PDUFA date for FDA’s decision on the application is Feb’22

  | Ref: Businesswire | Image: Linkedin