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Panzyga: New drug for chronic inflammatory demyelinating polyneuropathy
Panzyga: New drug for chronic inflammatory demyelinating polyneuropathy(CIDP)! U.S. FDA approves Pfizer Panzyga (human immunoglobulin for injection)!
Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has approved a supplementary biological product license application (sBLA) for Panzyga (human immunoglobulin for intravenous injection, 10% liquid preparation) for the treatment of chronic inflammation Adult patients with sexual demyelinating polyneuropathy (CIDP).
CIDP is a rare autoimmune-mediated polyneuropathy. Intravenous immunoglobulin (IVIg) is the most common first-line treatment for patients with CIDP.
It is worth mentioning that Panzyga is the only IVIg with 2 FDA-approved CIDP maintenance dosing regimens, which will help meet the clinical needs of patients. Panzyga can also be administered at an infusion rate of 12 mg/kg/min.
Panzyga is a 10% human normal immunoglobulin solution that is administered intravenously. In the United States, Panzyga was approved in 2018:
(1) For patients ≥ 2 years old to treat primary immunodeficiency (PI);
(2) Used in adult patients to treat chronic immune thrombocytopenia (cITP).
Pfizer signed a license agreement with Octapharma AG, under which Pfizer was granted the right to sell and commercialize Panzyga in the United States. Octapharma AG reserves the exclusive right to commercialize this product in the global market outside the United States.
Angela Lukin, Global President of Pfizer Hospitals Business Unit, said: “Every CIDP patient has different treatment needs. We found that only one approved dosage option is not always the best. This new indication and additional dosage option The approval will enable healthcare providers to choose a dosage option suitable for patients, which will help solve an unmet medical need in the patient population.”
CIDP is a rare peripheral nerve disease characterized by increasing symmetrical motor and sensory loss and weakness associated with loss of deep tendon reflexes. The disease is caused by damage to the nerve myelin sheath.
The gradual onset of CIDP can delay diagnosis for months or even years, leading to severe nerve damage, limiting and delaying response to treatment. Most patients require long-term treatment; if left untreated, nearly one-third of CIDP patients will develop wheelchair dependence. Early recognition and appropriate treatment are essential to help patients avoid developing severe disabilities.
The approval of this new indication is based on data from a prospective, double-blind, randomized, multicenter phase 3 study of 142 patients diagnosed with CIDP. This Phase 3 study is the first and only IVIg CIDP treatment study that has evaluated more than one maintenance dose option. In the study, over a period of 6 months, the efficacy, safety and tolerability of 7 maintenance infusions were evaluated every 3 weeks.
The primary efficacy endpoint is the proportion of responders in the 1.0 g/kg Panzyga treatment group compared to baseline at 6 months of treatment. Remission was defined as: a patient whose adjusted 10-point Inflammatory Neuropathy Cause and Treatment (INCAT) disability score decreased by at least 1 point.
The results showed that at the end of 6 months of treatment, 80% (55/69) of the patients achieved INCAT remission at a dose of 1.0 g/kg, reaching the primary endpoint of the study. Multiple supportive endpoints showed a dose-dependent efficacy, including the 2.0 g/kg dose group adjusted INCAT score showing a 92% remission rate. In the 1.0 g/kg and 2.0 g/kg dose groups, the grip strength, Inflammatory Raschig Comprehensive Disability Scale (I-RODS) and Medical Research Council (MRC) total scores also showed a dose-dependent response.
In this study, Panzyga was generally well tolerated. The most common adverse reactions (>5%) in all dose groups were headache (15%), fever (14%), dermatitis (10%) and increased blood pressure (8%). During the study period, 11 patients (8%) received premedication.
(source:internet, reference only)