EU Union grants orphan drug designation to ARA 290
Release Date: 14-Dec-2016
Araim Pharmaceuticals, drug Development Company announced that its lead product, innate repair receptor activator ARA 290, has been designated as orphan drug by European Commission for the prevention of graft loss in pancreatic islet transplantation. The U.S Food and Drug Administration (FDA) have previously granted orphan drug status to ARA290 for treatment to increase survival and improve functioning of pancreatic islets following transplantation.
Pancreatic islet transplantation is a prominent treatment option for patients with severe T1D characterized by significant metabolic instability and frequent life-threatening hypoglycemic episodes. Presently, currently islet cell transplantation requires that each recipient receive a large number of islets, as the procedure causes an inflammatory reaction which destroys a significant proportion of the administered islets.
The FDA and EMA’s designation of orphan status is granted to encourage new developments and therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval
For Orphan Drug Clinical Insight Reports Contact: email@example.com
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