thalidomide info in the United States:
Orphan drug status for Crohn's disease medication
* The U.S. Food and Drug Administration has granted orphan drug status to
Celgene Corp.'s Thalomid(tm) (thalidomide) for the treatment of Crohn's
disease, a chronic intestinal tract inflammatory disease.
* note: orphan drug status entitles Celgene to exclusive marketing rights
in the United States on thalidomide for seven years following marketing
approval, enables the company to obtain research funding and tax credits
for some research expenses, and grants a waiver for the drug's application
user fee.
* Thalomid, which is already approved for use in the U.S. to treat
erythema nodosum leprosum (ENL) in leprosy, is contraindicated in pregnant
women and those who may become pregnant; adverse reactions associated with
the drug include: peripheral neuropathy, drowsiness/somnolence,
dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral
load.
* data taken from a Celgene Corp. release (April 16, 1999).
In connection,
Judith Winter
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