Vericel (VCEL) FDA Approval of Epicel HDE Supplement - BUY

February 22, 2016 8:47am

Revised product label includes indication for use in pediatric patients and now specifies a “probable benefit” of Epicel; VCEL closed at $2.02 and is UP in the pre-market +$0.33 or +16.34% to $2.35

The U.S. FDA has approved its Humanitarian Device Exemption (HDE) supplement for Epicel® (cultured epidermal autografts) to revise the labeled indications of use to specifically include pediatric patients and to add pediatric labeling. 

The revised product label also specifies that the probable benefit of Epicel, mainly related to survival, was demonstrated in two Epicel clinical experience databases and a randomized, controlled, independent physician-sponsored study comparing outcomes in patients with severe burns treated with Epicel and standard care compared to standard care alone.

The Bottom Line: It’s all about … the “probable survival benefit” for adult and pediatric patients with life-threatening injuries resulting from severe burns. Love the word play … but, survival benefit? Why complain or justify "label changes" ...

VCEL closed at $2.02 and is UP in the pre-market +$0.33 or +16.34% to $2.35

Data from a clinical database used to support the original Epicel HDE application, which included 552 patients treated with Epicel from 1989 to 1996 (mean TBSA burns of 68.6%), including 205 pediatric patients aged 21 years and younger, demonstrated a survival rate of 86.6% for all patients and 89.3% for pediatric patients at three months post-initial surgery.  Data from the Epicel Medical Device Tracker, a post-approval registry of 402 patients treated with Epicel from October 2007 to June 2015 (mean TBSA burns of 66.0%), including 120 pediatric patients, demonstrated a survival rate of 81.3% for all patients and 88.3% for pediatric patients.

Data from the randomized, controlled, independent, physician-sponsored study of severe burn patients followed over a seven-year period demonstrated a survival rate of 90% for patients treated with Epicel (n=20, mean TBSA burns of 69.1%) and standard care, meaning excision plus allografting and/or split-thickness autografting, compared to a survival rate of 37.5% for patients in the control group (n=24, mean TBSA burns of 62.9%) who received standard care alone.

Epicel® (cultured epidermal autografts) is a permanent skin replacement indicated for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area greater than or equal to 30%.  Epicel may be used in conjunction with split-thickness autografts or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.  The probable benefit of Epicel, mainly related to survival, was demonstrated in two Epicel databases and one physician-sponsored study.  Epicel has been used in the United States and internationally to treat severely burned patients since 1988, and was approved in the United States in 2007 as a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE).