Seelos Therapeutics (NASDAQ:SEEL) received a positive opinion on European orphan drug designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the EMA committee for orphan medicinal products.
The positive opinion will be sent to the European Commission, which is expected to grant the orphan designation within 30 days. In November, SLS-005 was granted orphan drug designation from the FDA for ALS.
Under orphan designation in the 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.