Biotest wins US approval for new immunodeficiency therapy

Biotest has earned a key regulatory approval in the US for Bivigam, a new intravenous immune human globulin 10 percent liquid therapy.

The US Food and Drug Administration has ratified the drug for the treatment of primary humoral immunodeficiency, based on positive data from a pivotal clinical study demonstrating its safety, efficacy and tolerability.

Bivigam is the first polyspecific intravenous immune globulin manufactured in the US by Biotest, after the company recently made a significant investment to expand its protein purification and product distribution capabilities by launching an advanced new American facility.

The product will be developed by Biotest Pharmaceuticals Corporation, which was formed in 2007 following the purchase of Nabi Biopharmaceuticals' biologics strategic business unit.

Professor Dr Gregor Schulz, chief executive officer of Biotest, said: "This will be another milestone in Biotest's long legacy of providing immune globulin products to patients around the globe."

Earlier this month, the firm named a number of new members to its management team for research and regulatory affairs, an area in which it is looking to strengthen its capabilities.