Health Boards
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.
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.
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.
Source: stiefel.com
“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.
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.
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.
Source: stiefel.com