FDA approves Pfizer PANZYGA® for new indication

 The first and only FDA-approved intravenous immunoglobulin with two maintenance dosing options for CIDP

 

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) 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). PANZYGA is the only intravenous immunoglobulin (IVIg) with two FDA-approved maintenance dosing options for CIDP, helping to meet the clinical needs of patients. PANZYGA can also be administered at infusion rates up to 12 mg/kg/min.

“Each patient with CIDP has different treatment needs, and we have found that having one approved dosing option is not always optimal,” said Angela Lukin, Global President, Hospital Business Unit, Pfizer Inc. “The approval of this new indication with additional dosing options helps address an unmet patient need by providing healthcare providers with the ability to choose an approved dose that's right for patients.”

CIDP is a rare disorder of the peripheral nerves characterized by gradually increasing symmetrical motor and sensory loss and weakness associated with loss of deep tendon reflexes. It is caused by damage to the covering of the nerves, called myelin. The gradual onset of CIDP can delay diagnosis by several months or even years, resulting in significant nerve damage that may limit and delay the response to therapy. Most individuals will require long term treatment; nearly a third of CIDP patients will progress to wheelchair dependence if left untreated. Early recognition and proper treatment are critical in helping patients avoid a significant amount of disability.

https://www.biospace.com/article/releases/u-s-fda-approves-panzyga-for-the-treatment-of-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-/