Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

February 15, 2021 Auto Bot Adults, approval, FDA, Pfizer, receives, regulatory, sBLA, Treatment 0

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

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

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