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Talecris presents safety data, seeks FDA approval for concentrated form of Prolastin for IV augmentation
RESEARCH TRIANGLE PARK, NC — Talecris Biotherapeutics today presented results from two phase III studies assessing the safety, tolerability and pharmacokinetic comparability of a more concentrated formulation of Prolastin® (Alpha1-Proteinase Inhibitor [Human]) produced via a modification of the current manufacturing process that incorporates technological changes.
Submissions for approval of the more concentrated formulation of Prolastin have been made to the Food and Drug Administration (FDA) in the United States and to the proper regulatory agency in Canada. A similar submission is planned for Europe.
Prolastin is indicated for the treatment of Alpha-1 Antitrypsin Deficiency, a genetic condition in which low levels of the essential blood protein alpha1-proteinase inhibitor (A1PI) can cause emphysema. The more concentrated formulation of Prolastin delivers the same quantity of protein within a smaller infusion volume, potentially cutting infusion time in half for most patients.
Data from these phase III studies presented at the annual meeting of the American Thoracic Society show that the more concentrated formulation of Prolastin had comparable pharmacokinetic and safety profiles to the currently marketed version of Prolastin.
