News
Talecris announces FDA approval of Prolastin-C, new concentrated version of Prolastin that cuts infusion time in half
RESEARCH TRIANGLE PARK, NC – Talecris Biotherapeutics today received approval from the US Food and Drug Administration (FDA) for PROLASTIN-C, a more concentrated version of Prolastin, the company’s augmentation therapy for Alpha-1 Antitrypsin Deficiency (Alpha-1).
PROLASTIN-C delivers twice as much active protein (AAT) per milliliter as Prolastin, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/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.
“The introduction of Prolastin revolutionized care for thousands of individuals with Alpha-1,” said John Walsh, President and CEO of the Alpha-1 Foundation. “We welcome PROLASTIN-C as an example of the ongoing commitment Talecris has made to the Alpha-1 community.”
The manufacturing process for PROLASTIN-C incorporates technological advances such as nanofiltration, a virus exclusion technology, and cation exchange chromatography, an additional purification step, the Talecris press release said.
