FDA Grants Approval for Stiefel Laboratories' Sorilux Foam, 0.005%

Published: Sep 28, 2012

RESEARCH TRIANGLE PARK, N.C., Sept. 28, 2012 /PRNewswire/ -- Stiefel, a GSK (NYSE:GSK) company, today announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. 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.

"Studies have shown that in at least 50 percent of psoriasis cases, the scalp is involved," said Susan Learned, PharmD, MD, PhD, Medicines Development Leader, Dermatology Research and Development, Stiefel. "We believe this additional indication for Sorilux Foam will help meet the needs of both patients and physicians."

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 3b 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. It is not for facial, oral, ophthalmic, or intravaginal use. More information about the clinical trial results can be found in the Full US Prescribing Information at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Sorilux_Foam.pdf.

About Plaque Psoriasis

Psoriasis is a chronic (life-long) skin disease. It occurs when the immune system "speeds up" the growth cycle of skin cells. A normal skin cell matures and falls off the body in about a month. For people with plaque psoriasis, it can take only three or four days for new skin cells to develop. Instead of falling off, the cells remain on the skin and form thickened patches (lesions or plaques). While plaque psoriasis is a chronic condition, many patients experience times when their symptoms improve or worsen.

Plaque psoriasis is the most common form of psoriasis. It typically causes raised, red lesions covered with silvery white scales. Plaque psoriasis can occur on any part of the body, but most commonly on the scalp, knees, elbows, and torso. Sometimes, the lesions can appear in the same place on the left and right sides of the body.

Important Safety Information

Patients should not use Sorilux Foam if they have been told by their doctor that they have a high level of calcium in their blood (hypercalcemia). The medicine in Sorilux Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, patients are advised to stop using Sorilux Foam until calcium levels return to normal.

Sorilux Foam is flammable. Patients should avoid fire, flame, or smoking during and right after applying Sorilux Foam to the skin.

Patients should avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Patients are advised to wear a hat and clothes that cover the treated areas of the skin if they have to be in sunlight.

The most common side effects of Sorilux Foam are redness and pain of the treated skin areas.

Sorilux Foam is for use on the skin only. It is not for facial, oral, ophthalmic, or intravaginal use.

Patients should tell their doctor if they are pregnant or planning to become pregnant. It is not known if Sorilux Foam can harm an unborn baby.

Patients should tell their doctor if they are breastfeeding. It is not known if Sorilux Foam passes into breast milk. Patients are advised not to apply Sorilux Foam to the chest area if they are breastfeeding a baby. This will help prevent the baby from accidently getting Sorilux Foam into his/her mouth.

Patients should tell their doctor if they are getting light therapy for their psoriasis.

Patients should tell their doctor if they have any other medical conditions.

Please see full US Prescribing Information, including Patient Information Leaflet, available at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Sorilux_Foam.pdf

About Stiefel, a GSK company

Stiefel, a GSK company, is committed to advancing Dermatology and skin science around the world in order to help people better achieve healthier skin. Stiefel's dedication to innovation, along with its focus on pharmaceutical, over-the-counter and aesthetic Dermatology products, has established Stiefel as a world leader in the skin health industry. To learn more about Stiefel, visit www.stiefel.com.

Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.

SOURCE Stiefel, a GSK company

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