FDA Puts the Brakes on Santhera’s Request for Accelerated Approval

The FDA has brushed off Santhera Pharmaceuticals’ request for accelerated approval of its Duchenne candidate Raxone, delaying Santhera’s prospects for the drug.

The company said that it had sought approval for the investigational drug in Duchenne muscular dystrophy patients not taking concomitant glucocorticoids. The request was based on a single Phase 3 trial, with another scheduled trial in the pipeline to test the drug for efficacy.

The agency rejected the company’s request, stating that it would wait for the second study’s results.