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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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