US Food and Drug Administration Grants Lin BioScience Rare Pediatric Disease Status for LBS-008 to Treat Stargardt Disease
September 17, 2018 at 10:15 am
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Lin BioScience announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to LBS-008, a first-in-class oral therapy for the treatment of Stargardt Disease. The Priority Review Voucher Program is intended to encourage development of therapies to prevent and treat rare pediatric diseases. If LBS-008 is approved by the FDA for Stargardt Disease, the RPD designation qualifies Lin BioScience for the Priority Review Voucher. The voucher, which can be sold or transferred to another entity, can be used by the sponsor to receive Priority Review for a future NDA or BLA submission and reduce the candidate's FDA review time from ten months to six months.
LIN BIOSCIENCE, INC. is a Taiwan-based company mainly engaged in the development of new pharmaceutical drugs. The Company is in the research and development and clinical trials stage. It has four major drugs in development, including LBS-008, LBS-007, LBS-009 and LBS-002, as well as two technical platforms of RBP4 and CDC7. LBS-008 is developed for dry macular degeneration which belongs to the best-selling drugs, and stel lesions which belongs to orphan drugs. LBS-007 is used in acute leukemia which belongs to orphan drugs, and solid tumors which belongs to the best-selling drugs. LBS-009 is used in non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and type 2 diabetes. LBS-002 is developed for primary brain cancer and metastatic brain cancer. RBP4 platform is used for metabolic diseases, and CDC7 platform is used for all cancers.