Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
Mon, 10/19/2009 - 5:46am
Talecris Biotherapeutics today 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, the market leader for over 20 years, PROLASTIN-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency, a genetic condition in which low levels of this essential protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT-deficient patients at risk for developing emphysema. 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 0.08 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 most common drug-related adverse reactions observed at a rate of >/=1% in subjects receiving PROLASTIN-C were chills, malaise, headache, rash, hot flush and pruritus. "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. "PROLASTIN-C is an example of the significant investments Talecris is making in research and development and manufacturing," said Steve Petteway, Ph.D., executive vice president, Research and Development. "Our single-minded goal is advancing the care of patients who rely on our products." PROLASTIN DIRECT, the exclusive distribution and health management program for PROLASTIN, will provide more information to patients in the U.S. about the transition to PROLASTIN-C. Information about the transition to PROLASTIN-C in other countries will be provided as regulatory approvals are granted.