Regulatory Decision Summary for PANZYGA

Panzyga is an effective therapeutic for restoration of deficient plasma immunoglobulin G levels when administered intravenously at doses between 200 and 800 mg/Kg body weight every 3 or 4 weeks. This is accompanied by a reduced risk of severe bacterial infection.

Panzyga is also effective in the treatment of Chronic Immune Thrombocytopenia when 1 gram given on 2 successive days, results in a rise in blood platelet count and reduced bleeding. Both of these conditions, PID and ITP, are serious medical conditions for which alternative treatments are currently limited.

The efficacy and safety of Panzyga were supported by three studies: two were for PID, one for ITP.

The first for PID was an efficacy study (NGAM-01) the second for the safety of high infusion rates (NGAM-05).

The single ITP study (NGAM-02) was primarily for efficacy.

The risks of administration are generally similar in kind between the treatment schedules for PID and ITP, though the higher dose regimen in ITP appears more likely to provoke uncommon reactions such as Aseptic Meningitis. Many others can be mitigated by well described procedures such as adequate hydration. The risks are clearly identified in the Product Monograph, do not differ from those posed by alternative IVIG preparations and are well understood by prescribers.

The benefits of IVIG are well established and there are few therapeutic alternatives. The adverse reactions are rare and generally reversible.