americanpharmaceuticalreviewSeptember 18, 2018
Tag: FDA , Stargardt Disease , LBS-008
"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," said 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 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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