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FDA Licenses Aralast for Antitrypsin Deficiency

Kate Traynor

Baxter Healthcare Corp. and Alpha Therapeutic Corp. recently announced that the Food and Drug Administration has approved the licensing of Aralast, an alpha-1 proteinase inhibitor product indicated as supportive therapy in patients with emphysema caused by a congenital deficiency of alpha-1 antitrypsin.

Baxter, which will distribute the product in the United States, acquired the rights to Aralast during negotiations last year with Alpha Therapeutics.

Deborah Spak, a Baxter spokeswoman, estimated that Aralast will be available around the end of March. She noted that packaging and labeling details for the product have not been finalized.

Congenital alpha-1 antitrypsin deficiency is characterized by the inability of the liver to produce adequate amounts of alpha-1 antitrypsin, a protein necessary for normal lung function. The lungs of people with the condition lose elasticity, resulting in the development of emphysema and other lung disorders.

According to information released by the companies, Aralast does not reverse lung damage but can prevent further pulmonary damage in people with the congenital disorder. Patients whose emphysema is caused by factors other than congenital alpha-1 antitrypsin deficiency should not receive Aralast therapy.

Aralast will compete with Bayer Corp.'s alpha-1 proteinase inhibitor product, Prolastin, which has been in short supply and is under restricted distribution through the company's Bayer Direct program.

Baxter will not use a restricted-distribution program to provide Aralast to customers, Spak said.