BRIEF—FDA grants Lin BioScience Rare Pediatric Disease status

Lin BioScience, a drug development company targeting untreatable conditions in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration 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.

"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, chief executive of Lin Bioscience.