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Celgene’s Apremilast Receives FDA Orphan Drug Designation

February 1, 2013

     On January 17, 2013, Celgene’s drug Apremilast receives FDA Orphan Drug Designation (ODD) for the treatment of Behcet’s disease.

        Apremilast (CC-10004) is a new oral agent that is under clinical development for the treatment of inflammatory autoimmune disorders, such as psoriatic arthritis, psoriasis, rheumatoid arthritis, and Behçet’s Disease. Apremilast is currently in Phase II clinical trials for Behcet’s Disease and in Phase III clinical trials for moderate-to-severe psoriasis and psoriatic arthritis.

The Orphan Druganaut Blog reports in August 2012 on the story of a graduate student team from Keck Graduate Institute (KGI) of Allied Life Sciences (Claremont, CA),  that receives on June 14, 2012, FDA Orphan Drug Designation (ODD) for Pentoxifylline for Behcet’s Disease. Graduate KGI student Stacy Crawford is part of the team that successfully wrote a FDA ODD application for Pentoxifylline. Ms. Crawford was diagnosed with the disease 12 years ago.

Facts about Behcet’s Disease

– An autoimmune disease resulting from damage to blood vessels

– Develops usually in those who are in their 20’s and 30’s

– Hard to diagnosis

– Currently no cure, and treatments are not always effective

– US prevalence rate is estimated at 1/20,000

– Prevalence rate in other countries is 1/10,000.

KGI August 21, 2012 Article titled, “KGI Student Team Receives Orphan-Drug Designation For Behcet’s Treatment”

NYU Langone Medical Center’s Behcet’s Syndrome Center.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

  1. When can we expect apremilast to be approved for the indication of Behcet’s Disease?

    • Thank you for visiting the Orphan Druganaut Blog. I will send you an E-Mail with the information that I find to answer your question over the weekend.

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