Research & Development
SELLAS granted European Orphan Drug Designation for AML treatment SLS009
8 July 2024 -

Late-stage clinical biopharmaceutical company SELLAS Life Sciences Group Inc (NASDAQ:SLS) announced on Monday that it has secured Orphan Drug Designation (ODD) from the European Commission for its novel therapy SLS009 targeting acute myeloid leukaemia (AML).

The designation incentivises the development of treatments for rare diseases which affect less than 5 in 10,000 people in the European Union.

ODD in Europe follows the same designation from the US Food and Drug Administration (FDA). SELLAS highlighted positive clinical trial data for AML patients resistant to venetoclax regimens and emphasised the European Medicines Agency's (EMA) recognition of potential benefit.

The company aims to leverage the EMA's protocol assistance to gain eventual regulatory approval in the European Union, alongside pursuing US approval with the FDA.