Seelos Seeks Natural History Data, Rare Disease and Orphan Drug Designations for SLS-005

Seelos Therapeutics and the U.S. Food and Drug Administration (FDA) are continuing to discuss the use of Sanfilippo syndrome natural history data as a control for a pivotal U.S. study of the investigational SLS-005 (trehalose) treatment. The biopharmaceutical company also has submitted requests for…

SLS-005 Granted FDA’s Rare Pediatric Disease Designation for Sanfilippo

The U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to Seelos Therapeutics‘ SLS-005 (trehalose) to treat Sanfilippo syndrome, the company has announced. The designation is granted to product applications for diseases that affect fewer than 200,000 children, 18 and younger, in the U.S. and provides certain…

FDA Grants Orphan Drug Status to SLS-005 for Treating Sanfilippo

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Seelos Therapeutics‘ SLS-005 (trehalose) to treat Sanfilippo syndrome, the company has announced. Orphan drug designation aims to encourage the development of therapies for rare and serious diseases, through benefits such as seven years of market…