SCHERING-PLOUGH’s ELOCON PEDIATRIC ATOPIC DERMATITIS INDICATION

SCHERING-PLOUGH's ELOCON PEDIATRIC ATOPIC DERMATITIS INDICATION received a favorable efficacy review from FDA's Dermatologic Drugs Advisory Committee but questions were raised about its safety in the pediatric population. The committee voted unanimously that Elocon (mometasone furoate 0.1%) ointment and cream are effective in treating atopic dermatitis for children two years of age and older, but split (4-3) on whether the data are sufficient to establish the safety of the drug. There was one abstention on the safety vote. Elocon, which has been on the market for five years for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, would be the first topical steroid to be approved for use in the pediatric age group. Committee members were troubled by the lack of data on extended use of the drug in children and its potential effects both on local toxicity and hypothalamic-pituitary-adrenal (HPA) axis suppression. Committee Chair Wilma Bergfield, MD, head of Clinical Research at the Cleveland Clinic Foundation's Department of Dermatology, said both areas should be studied further. Committee member Jonathan Wilkin, MD, director of the Ohio State University Department of Dermatology, expressed concern that approval could lead to extensive use of the product before the safety issue is settled. "I think approval of this is going to confer enormous marketing advantages. It will become, I think, the corticosteroid -- topically applied -- in the pediatric age group," said Wilkin. He added that "once these preparations are approved, the tendency is for over-use: these are chronic diseases." Schering-Plough presented study results on 159 patients under age 12 from four multi-center trials. The results showed Elocon to be 90-98% effective in reducing disease signs. The company monitored potential HPA axis suppression in 24 patients with particularly severe cases of atopic dermatitis for two to six weeks -- depending on when the dermatitis dissipated -- and found no substantive change in plasma cortisol levels as a measure of HPA axis function. There was no atrophy or other signs of local toxicity, said Edwin Peats, PhD, of Schering Plough's clinical research/dermatology division. Elocon was compared to hydrocortisone 1% cream. The committee and FDA had seen data for only 48 of the 159 pediatric patients studied because the company had submitted the rest of data in the original NDA filed for Elocon and not in the supplemental package. This bothered committee members, who cast their votes concerning safety contingent on subsequent reviews of all the data to ensure that results are consistent with the partial data. The issue of expanding the use of mometasone furoate into the pediatric population was brought to the Dermatologic Drugs Advisory Committee at a time when FDA is stepping up its efforts to expand drug labeling, where appropriate, to include pediatric indications. The committee voted unanimously that corticosteroid responsive dermatoses, including atopic dermatitis, are the same pathophysiologic disease entities in pediatric populations older than one month as they are in the adult population. The committee also voted unanimously that a Cortrosyn (Organon's synthetic subunit of ACTH) stimulation test using hydrocortisone as a control is an appropriate method to demonstrate the safety in future studies of corticosteroids for treating dermatoses in children. The number of patients to be studied under such a test was not determined.