NEWS
SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia
SELLAS Life Sciences Group announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a selective CDK9 inhibitor, for treating acute myeloid leukemia (AML).
This designation follows positive preliminary Phase 2 data and aligns with the previous FDA ODD. The designation provides financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval.
SLS009 is currently in a Phase 2a clinical trial evaluating its safety and efficacy. The trial targets a 20% response rate and a median survival over three months, focusing on patients with specific myelodysplasia-related mutations.
This designation follows positive preliminary Phase 2 data and aligns with the previous FDA ODD. The designation provides financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval.
SLS009 is currently in a Phase 2a clinical trial evaluating its safety and efficacy. The trial targets a 20% response rate and a median survival over three months, focusing on patients with specific myelodysplasia-related mutations.
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
Spread kindness and love. Life is short. Don’t let greed eat you.
2606Followers
107Following
28KVisitors
Follow
OK OK161 : Junk stock that hasn't gone up a bit and has been in a downward spiral