LEO Pharma Taclonex (calcipotriene and betamethasone dipropionate) topical suspension, 0.005%/0.064% has won FDA approval for body plaque psoriasis.
With the approval, the only once-daily, steroid-containing topical treatment is now indicated for both scalp and body plaque psoriasis for up to eight weeks.
Taclonex contains a vitamin D analog (calcipotriene) and a corticosteroid (betamethasone dipropionate).
The International Psoriasis Foundation founder Dr. Alan Menter said a once-daily application makes Taclonex topical suspension an effective choice of treatment for a number of psoriasis patients, with positive clinical results seen in a recent eight-week study.
"In addition to its prior approval for use on the scalp, it has been shown to be safe and effective for use on the body," Dr. Menter added.
Two phase III clinical studies, one conducted in patients with psoriasis on the scalp and the other one in patients with psoriasis on the body, demonstrated that Taclonex acheived controlled disease when compared to monotherapies or vehicle used alone.
LEO Pharma president and chief executive officer John Koconis said, "This most recent FDA approval offers a new, single treatment option for patients suffering from plaque psoriasis on both scalp and body locations, and we look forward to continuously driving patient-centered innovation in the field of dermatology in the years to come."
