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Baxter Receives Approval To Process ARALAST NP

Armen Hareyan's picture

Baxter received Food and Drug Administration approval to transfer ARALAST processing from a third party to Baxter.

ARALAST NP is a brand name referring to the therapy completely processed by Baxter. It is biologically equivalent to currently marketed ARALAST.

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ARALAST is a human alpha1 -- proteinase inhibitor (A1PI) indicated for chronic augmentation therapy in patients with hereditary emphysema, which is a genetic condition caused by a deficiency of A1PI in the lungs. People with this deficiency have reduced serum levels of A1PI, an important blood protein processed in the liver that can protect lung tissue from damage caused by enzymes that are released by white blood cells.

Alpha1-Antitrypsin deficiency affects an estimated 60,000 to 100,000 people in the United States. It is estimated more than 95 percent of those with AAT deficiency are undiagnosed. Without sufficient quantities of A1PI, patients develop lung damage. If untreated, A1PI deficiency can result in emphysema and premature death.

ARALAST is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15mg/dL) who have known antibody against IgA, since they may experience severe reactions, including a severe, potentially life-threatening allergic reaction to IgA, which may be present. The most common symptoms during the clinical study were headache (0.3%) and sleepiness (0.3%). Post-market adverse event data have indicated reports of infusion site pain associated with the administration of ARALAST. Pregnancy Category C, reproduction studies have not been conducted with ARALAST. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.