FDA approves new sNDA for Sorilux (Stiefel/GSK) to treat Plaque Psoriasis of the scalp

The FDA has approved a supplemental New Drug Application for Sorilux (calcipotriene) Foam, from Stiefel/GSK. The sNDA expands the indication for Sorilux Foam to include the topical treatment of Plaque Psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old. The treatment was approved in 2010 for skin treatment. The approval of Sorilux Foam for treatment of plaque psoriasis of the scalp was based on a multi-center, randomized, double-blind, vehicle-controlled pivotal Phase IIIb study of patients with moderate scalp and body Psoriasis. The most common side effects of Sorilux Foam were redness and pain of the treated skin areas. The incidence of these adverse reactions was similar between the body and scalp. It is for use on the skin only, not for facial, oral, ophthalmic, or intravaginal use.