NEW YORK, April 30, 2020 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. ( 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 21 CFR Part 316. 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.
https://www.fda.gov/industry/developing-products-rare-diseases-conditions
Contact Information:
Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. ( SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
[email protected]
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
