Seelos Gets Positive EMA Opinion On Orphan Drug Designation For SLS-005 In Sanfilippo Syndrome

(RTTNews) - Seelos Therapeutics Inc. (SEEL) said that it has received a positive opinion on European Orphan Drug Designation for SLS-005 in Sanfilippo syndrome 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, 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 April, SLS-005 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Sanfilippo syndrome.