U.S. FDA Approves Pfizer’s PANZYGA® for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults
Feb 16, 2021 23:58
CST Updated
23:58
Pfizer
Pharmaceutical R&D Developer
FDA
U.S. Food and Drug Administration
February 16, 2021 News /Bio ValleyBIOON/ --Pfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Panzyga (immune globulin intravenous [human], 10% liquid formulation) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rareAutoimmunityFor CIDP-mediated polyneuropathy, intravenous immunoglobulin (IVIg) is the most common first-line treatment.
It is worth noting that Panzyga is the only product with twoFDAIVIg approved for CIDP maintenance dosing regimens will help meet patients’ clinical needs. Panzyga can also be administered at an infusion rate of 12 mg/kg/min.
Panzyga is a 10% solution of human normal immunoglobulin administered intravenously. In the United States, Panzyga was approved in 2018 for: (1) the treatment of primary immunodeficiency (PI) in patients aged ≥2 years; and (2) the treatment of chronic immune thrombocytopenia (cITP) in adult patients.
Pfizer entered into a licensing agreement with Octapharma AG, under which Pfizer was granted the rights to market and commercialize Panzyga in the United States. Octapharma AG retains exclusive global commercialization rights for the product outside the United States.
Angela Lukin, Global President of Pfizer’s Hospital Business Division, stated, “Each patient with chronic inflammatory demyelinating polyneuropathy (CIDP) has unique treatment needs, and we have found that having only one approved dosage option is not always optimal. The approval of this new indication and additional dosage options will empower healthcare providers to select a dosage tailored to each patient, thereby helping to address an unmet medical need within this patient population.”
CIDP is a rare peripheral neuropathy characterized by progressively worsening symmetric motor and sensory loss, along with weakness associated with the loss of deep tendon reflexes. The disease is caused by damage to the nerve myelin sheath. The gradual onset of CIDP canDiagnosisDelays of months or even years can lead to severe nerve damage, limiting and delaying response to treatment. Most patients require long-term therapy; without treatment, nearly one-third of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) will become wheelchair-dependent. Early identification and appropriate treatment are crucial to help patients avoid progressing to severe disability.
The approval of this new indication is based on data from a prospective, double-blind, randomized, multicenter Phase 3 study involving 142 patients diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). This Phase 3 study is the first and only study evaluating more than one maintenance dose option for intravenous immunoglobulin (IVIg) treatment of CIDP. In the study, the efficacy, safety, and tolerability of seven maintenance infusions administered every three weeks over a six-month period were assessed. The primary efficacy endpoint was the proportion of responders in the 1.0 g/kg Panzyga treatment group at six months compared to baseline. Responders were defined as patients who achieved a reduction of at least one point in the adjusted 10-point Inflammatory Neuropathy Cause and Treatment (INCAT) disability score.
The results showed that at the end of 6 months of treatment, 80% (55/69) of patients achieved INCAT remission at a dose of 1.0 g/kg, meeting the primary endpoint of the study. Multiple supportive endpoints demonstrated dose-dependent efficacy, including a 92% remission rate in the adjusted INCAT score for the 2.0 g/kg dose group. Dose-dependent responses were also observed in grip strength, Inflammatory Rasch-built Overall Disability Scale (I-RODS), and Medical Research Council (MRC) sum scores in the 1.0 g/kg and 2.0 g/kg dose groups. Panzyga was generally well tolerated in this study. The most common across all dose groupsAdverse Reactions(>5%) were headache (15%), fever (14%), dermatitis (10%), and increased blood pressure (8%). During the study, 11 patients (8%) received premedication.(BioValley Bioon.com)