Lin BioScience announced that the 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 to 6 months.
“We continue to be encouraged by the regulatory support for LBS-008 and the opportunities provided by the Rare Pediatric Disease designation and the Priority Review Voucher Program,” stated Dr. Tom Lin, CEO of Lin Bioscience.
LBS-008 is a first-in-class oral therapy that prevents the buildup of toxins in the eye that cause Stargardt Disease and dry age-related macular degeneration (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 1 clinical trials. LBS-008 received both US and EU orphan drug designation in 2017 and 2018, respectively.