Seelos Therapeutics (SEEL) Receives Positive EMA Opinion on Orphan Drug Designation for SLS-005 (Trehalose) in Amyotrophic Lateral Sclerosis
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Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received a positive opinion on European Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).
The positive opinion issued by COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days. 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 more than 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 was previously granted Orphan Drug Designation from the FDA and EMA for Spinocerebellar Ataxia Type 3 (SCA3), Sanfilippo syndrome and Oculopharyngeal Muscular Dystrophy (OPMD). SLS-005 has also been granted Fast Track designation from the FDA for OPMD.
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