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Protalix's prGCD Gets Orphan Drug Status From FDA

Wed, 09/09/2009 - 4:53am
NEW YORK (AP) — Protalix BioTherapeutics Inc. said Tuesday the Food and Drug Administration will give priority review to its experimental Gaucher disease treatment prGCD, and may grant funding to clinical trials. Gaucher disease is an enzyme disorder that can cause liver and neurological problems. The FDA has sped up its review of prGCD due to manufacturing problems for another drug, Genzyme Corp.'s Cerezyme, which has created concerns of a shortage. Protalix said the FDA granted orphan drug status to prGCD. Orphan drug status is given to drugs that could treat diseases that affect 200,000 people or fewer, and it includes priority review, potentially faster review times, funding, and tax savings. Orphan drug status is given to products that could be significant improvements over currently available therapies. Last month, Protalix said prGCD would get a sped up "fast track" review from the FDA.

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