The Food and Drug Administration (FDA) has approved Panzyga® (intravenous immunoglobulin) [human] – ifas 10% liquid preparation; Pfizer), used to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.
The approval was based on data from a prospective, double-blind, multicenter study (ClinicalTrials.gov: NCT02638207) comparing two different maintenance doses of Panzyga in 142 adults (aged 18 to 83 years) with CIDP. Patients were randomly selected 1: 2: 1 to first receive a loading dose of 2 g / kg and then 0.5 g / kg, 1 g / kg or 2 g / kg according to their respective dose arm for 7 maintenance infusions at intervals of 3 weeks to receive during the 24-week dose evaluation phase; Those in the 0.5 g / kg and 1 g / kg arms had the option of rescue treatment with 2 consecutive infusions of 2 g / kg at 3 week intervals if the criteria were met.
The primary efficacy result was based on the proportion of responders, defined as a patient with a decrease in the adjusted 10-point INCAT disability score (Inflammatory Neuropathy Cause and Treatment) by at least 1 point.
The results showed that nearly 80% (55/69) of patients in the 1 g / kg arm responded to treatment. The results also showed a dose-dependent response based on the proportion of responders in the 2 g / kg dose arm in the adjusted INCAT disability score (91.7%; 33/36) and the proportion of responders in the 1 g / kg and 2 g / kg Low dose in grip strength (65.2% and 83.3%), the inflammatory Rasch scale for total disabilities (55.1% and 72.2%) and the total sum of the Medical Research Council (72.5% and 72.2%). 86.1%).
Based on these findings, the FDA approved two maintenance dosage options for CIDP. Treatment can also be administered at infusion rates up to 12 mg / kg / min. “Every patient with CIDP has different treatment needs, and we have found that an approved dosage option is not always optimal,” said Angela Lukin, global president of Pfizer Inc.’s Hospital business unit. “Approval of this new indication with additional dosage options helps to meet an unmet patient need by allowing healthcare providers to choose an approved dose that is appropriate for patients. ”
The most common treatment-related side effects reported in the study were headache, fever, dermatitis, and increased blood pressure. The Panzyga label also includes a box warning regarding the risk of thrombosis, renal dysfunction and acute kidney failure.
In addition to its CIDP approval, Panzyga is also indicated for the treatment of primary humoral immunodeficiency in patients 2 years of age and older and in adult patients with chronic immune thrombocytopenia to increase the platelet count to control or prevent bleeding.
Panzyga is supplied as a solution with 10% IgG (100 mg / ml) in disposable bottles of 1 g, 2.5 g, 5 g, 10 g, 20 g and 30 g.
References
- The US FDA approves Panzyga® for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). [press release]. New York, NY; Pfizer; February 12, 2021.
- Panzyga®. [package insert]. New York, NY: Pfizer; 2021.
This article originally appeared on MPR
