Research & Development
Lin BioScience announces US FDA RPD designation for LBS-008 to treat Stargardt Disease
18 September 2018 -

Drug development company Lin BioScience reported on Monday the receipt of the US Food and Drug Administration (FDA) Rare Pediatric Disease (RPD) designation for LBS-008 for the treatment of Stargardt Disease, an untreatable inherited condition that causes permanent vision loss in children during childhood and adolescence.

The company added that the US FDA Priority Review Voucher Programme is intended to encourage development of therapies to prevent and treat rare paediatric diseases.

Following LBS-008's approval by the US FDA for Stargardt Disease, the company qualifies 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 US FDA review time to six months.

According to the company, LBS-008 is a first-in-class oral therapy that prevents the buildup of toxins in the eye that cause Stargardt Disease and atrophic Age-related Macular Degeneration (dry AMD). The NIH's Blueprint Neurotherapeutics Network, which funded the therapy's discovery and development, provides support and funding through to the completion of Phase I clinical trials. LBS-008 received both US and EU orphan drug designation in 2017 and 2018, respectively.



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