Drug Development

U.S. FDA grants orphan drug status for lysosomal acid lipase product

Published in Immunotherapy Weekly, August 31st, 2005

Large Scale Biology Corporation (LSBC) announced that it has received Orphan Drug Designation for its recombinant human lysosomal acid lipase (LAL) therapeutic product from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA).

Approval of the designation was received less than 3 months after the company submitted its application, which required no revisions or amendments. Orphan drug designation is a necessary first step towards gaining regulatory approval for any product used to treat orphan patient populations.

LAL is a naturally occurring human enzyme involved in the metabolism of certain lipids, including...

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Source: Immunotherapy Weekly (2005-08-31)

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