Friday, May 28, 2021
Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on thedevelopment of therapies for central nervous system disorders and rare diseases, today announced it has received European OrphanDrug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).
Under orphan designation in the European Union (EU), Seelos stands to benefit from several incentives such as protocol assistance,reduced regulatory fees and market exclusivity. European guidelines for Orphan Drug Designation are for diseases affecting not morethan five in 10,000 people in the EU.In November, SLS-005 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for ALS. SLS-005 waspreviously granted Orphan Drug Designation from the FDA and EMA for Spinocerebellar Ataxia Type 3 (SCA3), Sanfilippo syndrome andOculopharyngeal Muscular Dystrophy (OPMD). SLS-005 has also been granted Fast Track designation from the FDA for OPMD