According to the Pharmacy Times, patients with chronic inflammatory demyelinating polyneuropathy (CIDP) now have a new and potentially more effective treatment option. After submitting its supplemental Biologics License Application (sBLA), Pfizer received approval for Panzyga, an intravenous immunoglobulin (IVIg). This therapy is the only IVIg with two approved maintenance dosing options for adults with CIDP, allowing for more targeted and personalized dosing.
Panzyga
Outside of CIDP, Panzyga is also approved to treat adult patients with chronic immune thrombocytopenia and both pediatric and adult patients with primary immunodeficiency. Altogether, the sBLA approval – and new treatment indication – hinged on data from a Phase 3 clinical trial evaluating multiple Panzyga doses for adult patients with CIDP. 142 patients enrolled. WebMD describes Panzyga as:
medication…used to strengthen the body’s natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections.
Interested in learning more about Panzyga? Check out the Panzyga website.
During the clinical trial, researchers evaluated Panzyga maintenance infusion safety, efficacy, and tolerability. Infusions were given every 3 weeks for a 6-month period. Overall, researchers wanted to understand how many people responded to 1.0g/kg Panzyga. In this case, a response was seen as lowering 1 point in the Inflammatory Neuropathy Cause and Treatment (INCAT) score. Panzyga was found to be extremely effective, with 80% response in the lower dose and 92% response in those receiving 2.0g/kg.
Although the treatment was relatively safe and well-tolerated, some side effects did occur. These included:
- High(er) blood pressure
- Headache
- Fever
- Dermatitis (skin irritation)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Some doctors believe that chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder, could also be considered an autoimmune disorder. In CIDP, the nerve roots and peripheral nerves become inflamed. As this inflammation occurs, the myelin sheath (protective coating on nerve fibers) degenerates, causing nerve fiber death and inhibiting communication. Altogether, CIDP is characterized by progressive muscle weakness and sensory function in the arms and legs. Without early diagnosis and treatment, some patients will require ambulatory support. Typically, CIDP affects males 2x more often than females. Symptom onset usually occurs around 50 years old. These symptoms include:
- Fatigue
- Tingling or numbness in the fingers and toes
- Numbness or decreased sensation
- Difficulty using arms, hands, legs, or feet
- Progressive muscle weakness
- Difficulty walking or breathing
- Changes in voice or speech, such as slurring or hoarseness
- Loss of coordination
