Brief. Bioinformatics - Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

Tópicos

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Resumo

Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

Resumo Limpo

face substanti obstacl develop new therapi rare diseas sponsor look repurpos drug alreadi approv condit use therapi treat rare diseas effort facilit repurpos speed deliveri new therapi peopl need establish new resourc rare diseas repurpos databas rdrd advantag repurpos compound includ demonstr efficaci clinic context observ toxic profil clear describ manufactur control creat rdrd match us food drug administr fda orphan design databas fda drug biolog product approv list rdrd list product receiv orphan status designationthat found promis treatment rare diseaseand though yet approv market rare diseas alreadi approv market treat diseas condit rdrd contain three tabl orphandesign product least one market approv common diseas indic n orphandesign product least one market approv rare diseas indic n orphandesign product market approv common rare diseas indic n data includ databas reconfigurationcrossindex inform alreadi releas fda offer sponsor new tool find special opportun develop nich therapi rare diseas patient

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