FDA approves topical suspension for body plaque psoriasis

The FDA has approved a 0.005% calcipotriene and 0.064% betamethasone dipropionate topical suspension for the treatment of body plaque psoriasis, according to a news release.

Taclonex Topical Suspension (LEO Pharma Inc.) is a once-daily, steroid-containing treatment combining vitamin D analog (calcipotriene) and corticosteroid (betamethasone dipropionate) for use up to 8 weeks, according to the release. The first-line, single treatment also is indicated for scalp plaque psoriasis in patients 18 years of age or older. Weekly dose should not exceed 100 g, according to the release.

Two phase III clinical studies included more than 1,600 patients with scalp psoriasis, and one phase III study involved more than 1,100 patients with body plaque psoriasis, with a higher percentage of patients treated with Taclonex achieving disease control compared with patients using monotherapies or vehicle alone, according to the release. Folliculitis and burning sensation of the skin were the most common adverse reactions in at least 1% of subjects treated with Taclonex, a rate higher than in vehicle-treated participants, according to the release.

“The most recent FDA approval offers a new, single treatment option for patients suffering from plaque psoriasis on both scalp and body locations,” John Koconis, LEO Pharma Inc. president and chief executive officer, said in the release.