RESEARCH TRIANGLE PARK, N.C., Oct. 19 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics (Nasdaq: TLCR) today received approval from the U.S. Food and Drug Administration 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 manu
|SOURCE Talecris Biotherapeutics|
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