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Skin Treatments Introduced in 2013

Type/Class of Therapy Generic/Trade/ Company Names Indication Approving Regulatory Agency
Acne Adapalene 0.1% + benzoyl peroxide 2.5% gel
Epiduo®
Galderma Laboratories
An expanded pediatric indication was granted for the treatment of acne in children starting at 9 years of age. The fixed-dosed combination anti-acne agent had been previously approved for patients ≥12 years of age. US FDA
Actinic Keratosis Ingenol mebutate gel (0.015%, 0.05%)
Picato®
Leo Pharma Inc.
Ingenol mebutate gel (derived from the Euphorbia peplus plant) received approval for the topical treatment of actinic keratosis. The 0.015% formulation is used once-daily on the face and scalp for 3 consecutive days, and the 0.05% gel is used once-daily on the trunk and extremities for 2 consecutive days. It was FDA approved in 2012. Health Canada
Anti-Fungal Agents Efinaconazole 10% topical solution
Jublia®
Valeant Canada LP
Approval was granted to this antifungal compound for the treatment of mild to moderate onychomycosis. It is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). Health Canada
Luliconazole 1% cream
Luzu®
Valeant Pharmaceuticals International
This novel imidazole drug was approved for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients ≥18 years of age US FDA
Basal Cell Carcinoma Vismodegib capsule
Erivedge®
Curis, Inc./Roche
This hedgehog pathway inhibitor was approved for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. FDA approval was granted in 2012. EuropeanCommission
Health Canada
TGA Australia
Cutaneous T-cell Lymphoma Mechlorethamine (nitrogen mustard) gel
Valchlor™
Ceptaris Therapeutics, Inc.
Marketing approval was granted to this orphan drug for the oncedaily topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. US FDA
Genital Warts Sinecatechins ointment
Veregen®
Medigene AG Triton Pharma
Marketing approval was granted to this topical keratinocyte activation inhibitor for treating external genital or perianal warts. The product contains a concentrate of catechins with a complex defined composition extracted from green tea leaves. Health Canada
Hereditary Angioedema C1-esterase inhibitor
Berinert®
CSL Behring
Health authorities in 23 European countries approved an extended use of this C1-esterase inhibitor (C1-INH) concentrate for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema in adult and pediatric patients undergoing medical, dental or surgical procedures. The therapy is self-administered by intravenous infusion for eligible and trained patients. European Commission
Herpes Labialis Acyclovir 50 mg buccal tablets
Sitavig®
BioAlliance Pharma
Acyclovir buccal tablets received approval for the treatment of recurring herpes labialis (cold sores). This novel formulation is available as a mucoadhesive tablet that is self-administered by placement on the gum, delivering a high concentration of acyclovir directly to the site of the cold sore infection. US FDA
Acyclovir 5% + hydrocortisone 1% cream
Xerese®
Valeant Canada
Approval was granted to this topical antiviral + anti-inflammatory corticosteroid combination therapy indicated for the early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (≥12 years of age). Health Canada
Injectable Fillers and Neurotoxins AbobotulinumtoxinA for injection
Dysport®
Ipsen/Medicis/Valeant
Marketing authorization was granted to this formulation of botulinum toxin type A for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults <65 years of age. Health Canada
Hyaluronic acid gel dermal filler
Juvéderm Voluma™XC
Allergan, Inc.
Approval was granted to this first and only crosslinked hyaluronic acid gel filler for the temporary correction of age-related volume loss in the cheek area in adults >21 years of age. Treatment is indicated for deep (subcutaneous and/or supraperiosteal) injection into facial tissue to temporarily restore volume and fullness to areas of the midface. US FDA
OnabotulinumtoxinA for injection
Botox® Cosmetic
Allergan, Inc.
This neuromuscular paralytic agent received an additional approved indication for the temporary improvement of moderate to severe lateral canthal lines (crow’s feet). With this approval, onabotulinumtoxinA is the only pharmaceutical indicated to treat both lateral canthal and glabellar lines. US FDA
Melanoma Dabrafenib mesilate capsule
Tafinlar™
GlaxoSmithKline Inc.
This BRAF kinase inhibitor was approved as a monotherapy oral treatment for unresectable or metastatic melanoma in adult patients whose tumors express the BRAF V600E gene mutation. Dabrafenib is not indicated for treating patients with wild-type BRAF melanoma. A validated test to identify BRAF V600 mutation status is required to determine treatment eligibility. Dabrafenib inhibits certain mutated BRAF kinases that activate the BRAF pathway and drive tumor cell growth. Health Canada
US FDA
Trametinib dimethyl sulfoxide tablet
Mekinist™
GlaxoSmithKline Inc.
This first-in-class MEK1/MEK2 inhibitor was approved as a monotherapy oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations. These mutations must be detected by a validated companion diagnostic to confirm treatment eligibility. It is not indicated for patients who have progressed on a prior BRAF inhibitor therapy. Trametinib specifically binds to and inhibits MEK 1 and 2, resulting in inhibition of growth factor-mediated cell signalling and cellular proliferation in various cancers. Health Canada
US FDA
Psoriasis Infliximab
Inflectra™
Hospira, Inc.
Europe’s first biosimilar monoclonal antibody (mAb) therapy was approved for the treatment of inflammatory diseases including psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. Infliximab (innovator product Remicade®, Janssen) is a chimeric humanmurine mAb that binds with high affinity to tumor necrosis factoralpha (TNF-α). This drug is the first mAb to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. European Commission
Itolizumab
Alzumab™
Biocon Limited
This first-in-class novel anti-CD6 humanized monoclonal antibody was approved for the treatment of moderate to severe chronic plaque psoriasis. Drugs Controller General of India (DCGI)
Methotrexate injection
Otrexup™
Antares Pharma, Inc.
Approval was granted to this subcutaneous (SC) methotrexate (MTX) for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy in adults. It is the first FDA-approved SC MTX for once-weekly selfadministration delivered with a single-dose, disposable auto injector. US FDA
Psoriatic Arthritis Certolizumab pegol
Cimzia®
UCB, Inc.
Approval was granted for the treatment of adult patients with active psoriatic arthritis, which represents the third US approved indication for this humanized TNF-α inhibitor mAb. US FDA
Infliximab
Inflectra™
Hospira, Inc.
Europe’s first biosimilar mAb therapy was approved for the treatment of inflammatory diseases including psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. European Commission
Ustekinumab
Stelara®
Janssen Biotech, Inc.
An additional indication was granted to this fully human antiinterleukin (IL)-12 and anti-IL-23 mAb for use alone or in combination with methotrexate, for the treatment of adult patients aged ≥18 years with active psoriatic arthritis. US FDA
Brimonidine tartrate 0.33% topical gel Mirvaso®
Mirvaso®
Galderma Laboratories, L.P.
This topical treatment was approved for facial erythema (redness) of rosacea in adults ≥18 years of age. It is not indicated for the treatment of inflammatory lesions (papules and pustules). Brimonidine constricts dilated facial blood vessels to reduce the redness of rosacea. US FDA
Other Polidocanol 1% injectable foam
Varithena™
BTG plc
Approval of this sclerosing agent was granted for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. It is a minimally invasive, nonsurgical procedure that does not require tumescent anesthesia or sedation, and improves the symptoms and appearance for a range of varicose veins. US FDA
Smallpox vaccine
Imvamune®
Bavarian Nordic A/S
Approval was granted to Imvamune® for active immunization against smallpox in a public health emergency. Treatment is indicated for persons ≥18 years of age who are contraindicated to replicating smallpox vaccines, including individuals with immune deficiencies and skin disorders. Health Canada
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In this issue:

  1. Metastatic Melanoma: Optimizing Outcomes by Managing Dermatologic Toxicities Associated with Novel Therapies
  2. Skin Treatments Introduced in 2013
  3. Update on Drugs and Drug News - March-April 2014