Seelos Therapeutics Receives Orphan Drug Designation for SLS-005 (Trehalose) in Sanfilippo Syndrome

NEW YORK, April 30, 2020 (GLOBE NEWSWIRE) -- 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 been granted Orphan Drug Designation (ODD) for SLS-005 in Sanfilippo syndrome from U.S. Food and Drug Administration (FDA).

SLS-005 was previously granted Orphan Drug Designation from the FDA and European Medicines Agency (EMA) for Spinocerebellar Ataxia Type 3 (SCA3) and Oculopharyngeal Muscular Dystrophy (OPMD) as well as Fast Track designation for OPMD.

Seelos also submitted its application to the FDA to request Rare Pediatric Disease Designation (RPDD) for SLS-005 and is awaiting a response.  

About Orphan Drug Designation (ODD)

The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at . Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.

Contact Information:

Anthony Marciano

Head of Corporate Communications

Seelos Therapeutics, Inc. (Nasdaq: SEEL)

300 Park Ave., 12th Fl

New York, NY 10022

(646) 293-2136