ROCHE'S SORIATANE TO REPLACE TEGOSIN?

Roche has received the backing of a Food and Drug Administration panel for its oral retinoid drug Soriatane (acitretin), the drug which is seen as a successor for its Tegosin (etretinate) in the treatment of severe psoriasis. Acitretin is already approved and marketed in 16 countries worldwide. It was first launched in 1988.

The company presented data from two clinical trials at the FDA advisory committee meeting. The efficacy of acitretin in terms of improving psoriasis scaling, erythema, thickness and percentage of body covered was comparable to that seen with etretinate, which was approved in the USA in 1986. The improvement over etretinate, however, lies in the pharmacokinetics of acitretin, which is the former's active metabolite. The mean half-life for acitretin is just two days, compared to 120 days for etretinate.

Roche hopes that the faster elimination rate with acitretin will allow for less restrictive labeling than was possible for etretinate. The latter is indicated only for patients who are unresponsive to or intolerant of standard therapy, including ultraviolet B light, psoralens plus UVA light, systemic corticosteroids and methotrexate. Roche believes that acitretin, with its high efficacy in certain types of psoriasis, such as the erythrodermic and pustular forms, should not be considered a "last resort" drug.