To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Orphan Drug Status To orBec (Beclomethasone Dipropionate) For Prevention Of Graft-Versus-Host-Disease URL: http://www.pslgroup.com/dg/2070BE.htm Doctor's Guide September 25, 2001
MIAMI, FL -- September 25, 2001 -- The U.S. Food and Drug Administration (FDA) recently granted Enteron Pharmaceuticals Inc., an Orphan Drug Designation for use of orBec™ (dual release beclomethasone dipropionate) to prevent graft-versus-host disease (GVHD), a life-threatening complication that affects the skin, liver, and gastrointestinal tract following bone marrow transplants. This is the second orphan drug designation that Enteron has received for orBec from the FDA. orBec previously received a designation to treat intestinal GVHD; this is the subject of an ongoing, pivotal, multi-center, phase III clinical trial. The FDA has also granted orBec Fast Track status for treatment of intestinal GVHD; this can expedite the review process.
orBec is an oral, dual-release formulation of beclomethasone dipropionate (BDP), a potent site-active corticosteroid drug. Beclomethasone dipropionate has previously been approved by the FDA, and it is currently being sold by GlaxoSmithKline, as Beconase®, in an inhaled and nasal formulation for treatment of asthma, allergic rhinitis, and nasal polyposis.
orBec allows larger doses of BDP to be delivered to the afflicted gastrointestinal area without systemic side effects associated with other steroids used to treat GVHD.
According to the National Bone Marrow Transplant Registry, 12,748 allogeneic bone marrow transplants (transplants of blood or bone marrow cells from another person) were performed worldwide during the first half of 2001. Bone marrow transplants are used to treat various types of cancer, including leukemia, as well as several diseases of the immune and hematopoietic system.
Despite the clinical success of such transplants, a significant number of patients experience GVHD and other side effects, making bone marrow transplants a high-risk, life-threatening procedure. Currently, there is no effective FDA-approved regimen to prevent GVHD from occurring. Preventing GVHD could reduce substantially the morbidity and mortality of bone marrow transplants, which in turn might allow the procedure to be applied to numerous malignant and genetic disorders.
The function of the FDA's Orphan Products Division is to encourage research and development of new therapies for rare diseases, where there is an unmet medical need. As a designated Orphan Drug, orBec is eligible for certain tax benefits based upon clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process. This designation gives Enteron the opportunity to obtain four to seven years of additional market exclusivity for orBec, from the date the drug is approved for use in preventing GVHD.
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