RARE Daily

FDA Approves Pfizer’s Panzyga to Treatment of Adults with CIDP

February 16, 2021

Rare Daily Staff

The U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Pfizer’s Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy.

Chronic inflammatory demyelinating polyneuropathy (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, and 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.

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. “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.”

The approval for this new indication was based on data from a prospective, double-blind, randomized, multi-center phase 3 study in 142 patients diagnosed with CIDP. This phase 3 study was the first and only IVIg CIDP treatment study to evaluate more than one maintenance dosing option.

Efficacy, safety, and tolerability were observed during seven maintenance infusions at three-week intervals over a six-month period.

Panzyga was generally well tolerated. The most common adverse reactions across all dosing arms were headache, fever, dermatitis, and blood pressure increase. During the study 11 patients received premedication.

The FDA approved Panzyga in 2018 for the treatment of primary immunodeficiency (PI) in patients two years of age and older and chronic immune thrombocytopenia (cITP) in adults.

Pfizer licenses rights to market and commercialize Panzyga in the United States from Octapharma, which retains exclusive rights to commercialize this product globally everywhere else.

Photo: Angela Lukin, global president, Hospital Business Unit, Pfizer

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