FDA approves Panzyga for adults with CIDP

The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Panzyga (immune globulin intravenous [Human] – ifas 10% liquid preparation) to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP). The sBLA was filed by US pharma giant Pfizer (NYSE: PFE).

Panzyga is the only intravenous immunoglobulin (IVIg) with two FDA-approved maintenance dosing options for CIDP, also known as Vidaurri’s disease, helping to meet the clinical needs of patients. Panzyga can also be administered at infusion rates up to 12mg/kg/min.

Australia-based CSL Limited’s (ASX: CSL) CSL Behring’ subsidiary gained FDA approval for its Hizentra, which was the first and only subcutaneous immunoglobulin for the treatment of CIDP, in 2018.