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# Pfizer sBLA Approved for Panzyga
- URL: https://www.fdaweb.com/pfizer-sbla-approved-for-panzyga/
- Published: 2021-02-16T12:00:00.000Z
- Updated: 2026-09-14T16:46:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148673

FDA has approved a Pfizer supplemental BLA for Panzyga (immune globulin intravenous \[human\] – ifas 10% liquid preparation) to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare peripheral nerve neurological disease. Approval was based on data from a Phase 3 study in 142 patients diagnosed with CIDP. The primary endpoint was met with 80% of patients in the study achieving a favorable Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, according to the company. The most common adverse reactions across all dosing arms were headache (15%), fever (14%), dermatitis (10%), and blood pressure increase (8%). Panzyga was approved in 2018 for treating primary immunodeficiency in patients two years of age and older and chronic immune thrombocytopenia in adults.