Panzyga was previously approved in the US to treat primary humoral immunodeficiency in people aged two years and above, and chronic immune thrombocytopenia in adults
Pfizer has secured the US Food and Drug Administration (FDA) approval for Panzyga (Immune Globulin Intravenous [Human] – ifas) to treat a rare neurological disease in adults.
The US FDA approved Pfizer’s supplemental Biologics License Application (sBLA) for Panzyga to treat a rare disease of peripheral nerves, dubbed chronic inflammatory demyelinating polyneuropathy (CIDP).
The drug was previously approved in the US, to treat primary humoral immunodeficiency (PI), in people aged 2 years and above, and chronic immune thrombocytopenia (cITP) in adults.
PI include congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Pfizer said that Panzyga is the only intravenous immunoglobulin (IVIg) with two FDA-approved maintenance dosing options for CIDP, to meet the clinical needs of patients.
Pfizer hospital business unit global president Angela Lukin said: “Each patient with CIDP has different treatment needs, and we have found that having one approved dosing option is not always optimal.
“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 FDA approval is supported by data from a double-blind, randomised, multicentre Phase 3 study that evaluated the efficacy, safety, and tolerability of the drug.
In the study, 142 patients diagnosed with CIDP were given seven maintenance infusions at three-week intervals, for six months.
The primary efficacy endpoint of the study was the proportion of responders in the 1g/kg Panzyga treatment arm at six months relative to baseline.
Responders are patients with a reduction of at least one point in the adjusted 10-point Inflammatory Neuropathy Cause and Treatment (INCAT) disability score.
In the Phase 3 study, the most common adverse reactions include headache, fever, dermatitis, and blood pressure increase.
Pfizer has reached a license agreement with Octapharma, for the rights to market and commercialise Panzyga in the US. Octapharma retained the rights to commercialize the product outside of the US.
Pfizer stated that the drug is not advised for patients with a history of severe systemic hypersensitivity reactions, including anaphylaxis to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.