Talecris’s Prolastin-C Gets FDA Approval

Talecris Biotherapeutics (Talecris) has received approval from the FDA for Prolastin-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of Prolastin produced using advances in manufacturing technology.

Like Prolastin, Prolastin-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency. Reportedly, the active protein in Prolastin-C increases protein levels in AAT-deficient patients at risk for developing emphysema.

Talecris has said that Prolastin-C delivers twice the active protein per milliliter as Prolastin, cutting infusion volume and time in half when given at the recommended rate of 0.08ml/kg/min. Clinical studies have shown that Prolastin-C and Prolastin are equally effective at raising AAT levels in the blood, and that the adverse event profile of Prolastin-C is consistent with that of Prolastin.

John Walsh, president and CEO of the Alpha-1 Foundation, said: “The introduction of Prolastin revolutionized care for thousands of individuals with Alpha-1. We welcome Prolastin-C as an example of the ongoing commitment Talecris has made to the Alpha-1 community.”

Steve Petteway, executive vice president of Research and Cevelopement at Telecris, said: ” Prolastin-C is an example of the significant investments Talecris is making in research and development and manufacturing.”