Octapharma begins phase II/III testing of immunoglobulin therapy

Pharmaceutical Company Product News

Octapharma has begun a two-stage phase II/III clinical study of its new ten per cent intravenous immunoglobulin preparation (IVIG) for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

The trial of the new high-purity product is said to be the biggest ever study of an IVIG and is designed to collect data on the treatment's safety and efficacy.

Octapharma has already conducted studies to test the product's effectiveness against conditions such as thrombocytopenic purpura, Guillain-Barre syndrome and Kawasaki disease.

It is hoped that the data will demonstrate the treatment's advantages compared to Octapharma's current leading IVIG brand and support its regulatory filing in Europe and the US.

Dr Stefan Haag, head of the company's international immunotherapy business unit, said: "Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at high infusion rates."

This comes after the firm announced last month that it has applied for European approval of Uniplas, its new universal blood plasma treatment.

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