|Type/Class of Therapy
|Generic/Trade/ Company Names
|Approving Regulatory Agency
|Adapalene 0.1% + benzoyl peroxide 2.5% gel
|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.
|Ingenol mebutate gel (0.015%, 0.05%)
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.
|Efinaconazole 10% topical solution
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).
|Luliconazole 1% cream
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
|Basal Cell Carcinoma
|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.
|Cutaneous T-cell Lymphoma
|Mechlorethamine (nitrogen mustard) gel
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.
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 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.
|Acyclovir 50 mg buccal tablets
|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.
|Acyclovir 5% +
hydrocortisone 1% cream
|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).
|Injectable Fillers and Neurotoxins
|AbobotulinumtoxinA for injection
|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.
|Hyaluronic acid gel dermal filler
|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.
|OnabotulinumtoxinA for injection
|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.
|Dabrafenib mesilate capsule
|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.
|Trametinib dimethyl sulfoxide tablet
|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.
|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.
|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)
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.
|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.
|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.
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.
|Brimonidine tartrate 0.33% topical gel
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.
|Polidocanol 1% injectable foam
|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.
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.