new info wbbs:
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Mr. Eidswick,
Aimspro received Orphan Drug Designation from the FDA back in 2011 but only for the treatment of systemic sclerosis (scleroderma). This Orphan Drug Designation grants special status to medication to treat a rare disease or condition upon request of a sponsor and if the disease or condition for which the drug is intended affects fewer than 200,000 people in the United States. In addition, the drug to treat the rare disease or condition must meet strict FDA criteria. There are currently clinical trials with Aimspro in Multiple Sclerosis. Aimspro has already achieved TGA Orphan Status in Australia for the treatment of both ALS and Krabbe Leukodystrophy (Krabbe's disease). In the UK, Aimspro is only available under their “compassionate-use” regulations and that means patients have to pony up the money instead of insurance.
I pulled up the FDA list of Orphan Drug designations for neurology and did not find Aimspro on the list. I will ask Dr. Appel what he knows about the drug and ALS.
Best wishes,
Luis
Luis F. Lay, Jr.
Academic Senior Research Coordinator
Houston Methodist Research Institute
Houston Methodist Neurological Institute
6560 Fannin, Suite 802
Houston, Texas 77030
Tel: (713)441-3057
Fax: (713) 793-7273
Cell: (713) 501-8676
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