FDA Approvals Roundup: Enjaymo and Fleqsuvy

New approvals 

Enjaymo okayed a first treatment for cold agglutinin disease 

Sanofi’s Enjaymo (sutimlimab-jome; injection) has been approved for decreasing the need for hemolysis-related red blood cell (RBC) transfusion in adults with cold agglutinin disease (CAD). The autoimmune  disease is characterized by hemolysis, which is the destruction of red blood cells. 

Approval of Enjaymo was based on findings from the open-label, single-arm CARDINAL trial in which 24 patients from the indicated population received the study drug for up to 6 months, after which they could opt to continue in an extension phase of the trial. In all, at 6 months, 54% of patients responded to the treatment. In addition, 63% of patients showed an increase of ≥2 g/dL in in hemoglobin level; 71% did not received an RBC transfusion after the first 5 weeks of treatment; and 92% needed no other therapies for CAD. 

This biologics license application received orphan drug and breakthrough therapy designations and was granted priority review. 

Fleqsuvy approved for MS-related spasticity and spinal cord injury, disease 

Azurity’s Fleqsuvy (baclofen; oral suspension) has been approved for treating spasticity related to multiple sclerosis or spinal cord injuries or diseases. 

Approval of the antispasmodic agent was based on a demonstration of similar bioavailability in a pharmacokinetic study comparing baclofen oral tablets and Fleqsuvy in healthy adults.