Shots:

• The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy- safety- and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos. period
• The study met 1EPs i.e. 80% of patients achieved INCAT response with 1.0 g/kg dose. Dose-dependent responses demonstrate 1.0 g/kg and 2.0 g/kg dose arms in grip strength- I-RODS- and MRC sum scores and were well tolerated
• Panzyga is the only IVIg with two FDA-approved maintenance dosing options for CIDP and has received the US FDA’s approval in 2018 for PI and cITP in adults

 ­ Ref: Pfizer | Image: Pfizer