Health Boards
Leo Pharma have announce that their Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% (Enstilar) has been accpeted by the FDA for the treatment of Plaque Psoriasis.
Source: leo-pharma.com
Quote:
LEO Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) Foam for the treatment of psoriasis vulgaris in patients 18 years of age or older in the United States.1 Enstilar® is a once-daily, alcohol-free topical treatment.
“We are very pleased by the U.S. approval of Enstilar® and believe it will provide patients with the type of treatment option that they are looking for,” said Gitte Aabo, President and CEO of LEO Pharma. “At LEO Pharma, we are committed to providing patients with innovative, new solutions and we believe the foam formulation of Enstilar® can help patients living with psoriasis.”
Enstilar® was developed to treat patients with psoriasis vulgaris – the most common clinical form of psoriasis.
The U.S. approval of Enstilar® was based on the Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period,5 and the Phase 2 MUSE safety profile study.6 In the pivotal Phase 3 PSO-FAST clinical trial, over half of patients treated with Enstilar® were “Clear” or “Almost Clear” by Week 4 as measured by the 2-step Investigator Global Assessment (IGA) improvement score.1 Additionally, more than half of patients treated with Enstilar® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.
In March 2015, LEO Pharma submitted Marketing Authorisation Applications to 30 European Health Authorities for Enstilar®; however, the product is currently only approved for use in the U.S.
Enstilar® combines a vitamin D analogue (calcipotriol) with a potent corticosteroid (betamethasone dipropionate) to achieve a normalizing result on the affected skin cells and promote a greater anti-inflammatory response than the monotherapy components alone in patients suffering from psoriasis vulgaris.
Apply Enstilar® to affected areas once daily for up to 4 weeks. Patients should discontinue use when control is achieved. Instruct patients not to use more than 60 g every 4 days.
INDICATION AND USAGE
Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
Apply Enstilar® to affected areas once daily for up to 4 weeks. Patients should discontinue use when control is achieved. Instruct patients not to use more than 60 g every 4 days.
IMPORTANT SAFETY INFORMATION
For topical use only. Enstilar® is not for oral, ophthalmic, or intravaginal use. Instruct patients to avoid use on the face, groin, or axillae, or if atrophy is present at the treatment site, and not to use with occlusive dressings, unless directed by a physician.
The propellants in Enstilar® are flammable. Instruct patients to avoid fire, flame, or smoking during and immediately after using this product.
Hypercalcemia and hypercalciuria have been observed with use of Enstilar® Foam. If hypercalcemia or hypercalciuria develop, patients should discontinue treatment until parameters of calcium metabolism have normalized.
Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Risk factors include use of high-potency topical corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.
Adverse reactions reported in <1% of subjects treated with Enstilar® in clinical trials included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.
Patients who apply Enstilar® to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. You may wish to limit or avoid use of phototherapy in patients who use Enstilar®.
There are no adequate and well-controlled studies of Enstilar® in pregnant women. Enstilar® should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Enstilar® is administered to a nursing woman. Do not use Enstilar® on the breast when nursing.
The safety and effectiveness of Enstilar® in pediatric patients have not been studied.
Source: leo-pharma.com