Amgen sBLA for Enbrel accepted by the FDA for review

Amgen announced last week that its supplemental Biologics License Application (sBLA) for the extended use of Enbrel (etanercept) in the treatment of chronic severe plaque psoriasis in pediatric patients has been accepted for review by the U.S. Food and Drug Administration (FDA).

If Enbrel is approved for extended use by the FDA, it will become the first systemic medication approved for the treatment of pediatric patients with chronic severe plaque psoriasis in the United States. There is a current need for medication to combat the disease in pediatric patients and Enbrel could become a viable treatment option if the FDA approves the drug.

Amgen submitted the sBLA for Enbrel on Jan. 5 based on data collected from a Phase 3 study that took place over the span of a year and its five-year study to assess safety and efficiency that would extend the open label to cover pediatric patients with moderate to severe plaque psoriasis.

The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for the sBLA for Enbrel is Nov. 5.