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news.Octapharma has submitted biological license application (BLA) for octaplasLG to the FDA, to expand its US product portfolio.
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The FDA will evaluate the BLA for an indication of managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors, the company said.
The BLA seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura.
The product features solvent/detergent inactivation against enveloped viruses and immune neutralization against non-enveloped viruses.
Octapharma USA president Flemming Nielsen said this trusted therapy has been successfully used to treat patients for more than 15 years in Europe and over 30 countries worldwide.
Thrombotic thrombocytopenic purpura is a blood disorder that causes clot formation in small blood vessels.