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Skin Treatments Introduced in 2016

Skin Therapy Letter uses reasonable efforts to include accurate and up-to-date information, we make no warranties or representations as to the accuracy, completeness, timeliness or reliability of the content and assume no liability or responsibility for any error or omission. The content primarily focuses on approvals issued by US and Canadian drug regulatory agencies.

Type/Class of Therapy Generic/Trade/Company Names Indication Approving Regulatory Agency
Actinic Keratosis PDT for actinic keratosis
Ameluz® gel + BF-RhodoLED®
Biofrontera AG
Approval was granted to the topical drug Ameluz® (aminolevulinic acid, a porphyrin precursor) for use in combination with the BF-RhodoLED® lamp for photodynamic therapy (PDT) treatment of mild to moderate actinic keratoses on the face and scalp. This approval covers lesion-directed as well as field-directed treatment. US FDA
Anti-acne Agents Adapalene 0.1% gel
Differin® Gel
Galderma Laboratories, L.P.
This approval makes Differin® Gel the first and only OTC acne product containing a full prescription-strength retinoid. It also marks the first new FDA-approved active ingredient to be introduced to the OTC acne category in over 3 decades. US FDA
Dapsone 7.5% gel
Aczone®
Allergan plc.
Dapsone 7.5% gel was approved for the once-daily topical treatment of acne in patients ≥12 years of age. This agent treats both inflammatory and non-inflammatory acne with a new concentration of dapsone. US FDA
Antibacterial Agents Ceftaroline fosamil
Teflaro®
Allergan plc.
A supplemental New Drug Application was granted to ceftaroline fosamil, an IV antibiotic, extending new indications for pediatric patients 2 months to <18 years of age with acute bacterial skin and skin structure infections. US FDA
Anti-cancer Agents Cobimetinib + vemurafenib
Cotellic™ + Zelboraf®
Hoffmann-La Roche Limited
(Roche Canada)
Cobimetinib (MEK-inhibitor) was approved for use in combination with vemurafenib (BRAF-inhibitor), as an oral treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. European and US approvals were gained in 2015. Health Canada
Nivolumab + ipilimumab
Opdivo® + Yervoy®
Bristol-Myers Squibb Company
Approval was granted to nivolumab (Opdivo®, anti-PD-1 monoclonal antibody) in combination with ipilimumab (Yervoy®, anti-CTLA-4 monoclonal antibody) for the treatment of advanced (unresectable or metastatic) melanoma in adults. European Commission

Health Canada

US FDA
Pembrolizumab IV injection
Keytruda®
Merck & Co.
Pembrolizumab was approved for the treatment of patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Pembrolizumab is now the first and only anti-PD1 agent approved for first-line treatment regardless of BRAF mutation status. Health Canada
Atopic Dermatitis Crisaborole 2% ointment
Eucrisa™ (formerly AN2728)
Pfizer Inc.
Crisaborole ointment was approved to treat mild-to-moderate eczema (atopic dermatitis, AD) in patients ≥2 years of age. Cisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor. US FDA
Dermal Fillers Dermal filler with calcium
hydroxylapatite (CaHA) + integral 0.3% lidocaine
Radiesse® Lidocaine
Merz Pharma
CE mark certification was granted to Radiesse® Lidocaine, an injectable implant dermal filler that contains a small quantity of the local anesthetic lidocaine. In Europe, Radiesse® Lidocaine is indicated for plastic/reconstructive procedures, including deep dermal and subdermal soft tissue augmentation of the facial area and for restoration and correction of facial volume loss. European Commission
Hyaluronic acid (HA) gel filler
Juvéderm Volbella® XC
Allergan plc
Approval was granted to market Juvéderm Volbella® XC for use in the lips for lip augmentation and correction of perioral rhytids, commonly referred to as perioral lines, in adults >21 years of age. US FDA
HA dermal fillers
Restylane® Refyne
Restylane® Defyne
Galderma Laboratories
These HA-based dermal fillers were approved for the treatment of nasolabial folds or "laugh lines" in patients >21 years of age. Restylane® Refyne was approved for moderate-to-severe facial wrinkles and folds, and Restylane® Defyne was approved for treating moderate-to-severe, deep facial wrinkles and folds. US FDA
Hemangioma Propranolol hydrochloride oral solution 3.75 mg/ml
Hemangiol®
Pierre Fabre Dermo-Cosmétique
The beta-adrenergic blocker propranolol hydrochloride was approved for the treatment of proliferating infantile hemangioma requiring systemic therapy. Treatment should be initiated in infants 5 weeks to 5 months. Age for treatment initiation should be corrected in case of prematurity. Health Canada
Hereditary Angioedema C1 esterase inhibitor (human) for IV infusion
Berinert®
CSL Behring
Approved indications of C1 esterase inhibitor (human) broadened to include the treatment of hereditary angioedema (HAE) attacks in pediatric patients. This expands the use of Berinert® into all age groups, making it the first and only approved HAE treatment available to patients <12 years of age. US FDA
Hidradenitis Suppurativa Adalimumab for SC injection
Humira®
AbbVie Inc.
Adalimumab was approved for the treatment of adults with active moderate to severe hidradenitis suppurativa (HS, acne inversa), who have not responded to conventional therapy (including systemic antibiotics). This follows approval from both the FDA and the European Commission in 2015. Health Canada
Neuromodulator Botulinum toxin type A for injection (IncobotulinumtoxinA)
Bocoutur®
Merz Pharma
This formulation of botulinum toxin type A was approved for the treatment of upper facial lines, including horizontal frown lines, lateral periorbital lines and glabellar frown lines. Bocouture® is the only neurotoxin approved in Europe for the simultaneous treatment of upper facial lines. European Commission
Psoriasis Betamethasone dipropionate 0.05% spray
Sernivo™
Promius Pharma
Approval was granted to this topical corticosteroid spray formulation containing betamethasone dipropionate 0.05% for the treatment of mild to moderate plaque psoriasis in patients ≥18 years of age. US FDA
Calcipotriol + betamethasone dipropionate foam
Enstilar®
Leo Pharma
Scientific approval was granted to this fixed combination of calcipotriol/betamethasone dipropionate 50 micrograms/g / 0.5 mg/g for the treatment of psoriasis vulgaris in patients ≥18 years of age. European Commission

Health Canada
Brodalumab for SC injection
Lumicef®
Kyowa Hakko Kirin
This fully human anti-interleukin-17 (IL-17) receptor A antibody was approved as a second-line treatment for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma. Japan's Ministry of Health, Labour and Welfare (MHLW)
Ixekizumab for SC injection
Talz®
Eli Lilly and Company
Ixekizumab was approved for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. This humanized monoclonal antibody specifically targets interleukin (IL)-17A. European Commission

Health Canada

US FDA
Etanercept for SC injection
Enbrel®
Amgen Inc.
A supplemental Biologics License Application (sBLA) was approved for the expanded use of etanercept (Enbrel®), making it the first and only systemic therapy to treat pediatric patients aged 4 to 17 years with chronic moderate-to-severe plaque psoriasis. US FDA
Apremilast tablets
Otezla®
Celgene Corporation
This oral selective inhibitor of phosphodiesterase 4 (PDE4) was granted full marketing authorization for the treatment of adults with plaque psoriasis with an inadequate response to topical therapies, as well as adult patients with psoriatic arthritis. MHLW (Japan)
Ustekinumab for SC injection
Stelara®
Janssen Inc.
Ustekinumab, a fully human IL-12 and IL-23 antagonist, was approved for the treatment of chronic moderate-to-severe plaque psoriasis in adolescent patients aged 12 to 17 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. This marks the first biologic to gain regulatory approval for the treatment of moderate-to-severe psoriasis in adolescents. Health Canada
Adalimumab-atto for SC injection
Amjevita®
Amgen Inc.
The first biosimilar to adalimumab (Humira®), Amjevita™ was approved to treat seven inflammatory diseases, including psoriatic arthritis and moderate-to-severe chronic plaque psoriasis. US FDA
Etanercept-szzs for SC injection
Erelzi™
Sandoz Inc., a Novartis division
Erelzi™ (etanercept-szzs), a tumor necrosis factor blocker biosimilar to etanercept (Enbrel®) was approved for all indications included in the reference product label. US FDA
Biosimilar of infliximab
Flixabi®
Samsung Bioepis Co.
Flixabi® (also known as SB2), an infliximab biosimilar referencing Remicade®, was approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. European Commission
Infliximab-dyyb for IV infusion
Inflectra™
Hospira/Celltrion
Multiple indications were approved for Inflectra™, a biosimilar to infliximab (Remicade®). Approved uses include chronic severe plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. US FDA
Psoriatic Arthritis Brodalumab for SC injection
Lumicef®
Kyowa Hakko Kirin
This fully human anti-interleukin-17 (IL-17) receptor A antibody was approved as a second-line treatment for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma. MHLW (Japan)
Secukinumab for SC injection
Cosentyx®
Novartis AG
Expanded approval of secukinumab, a monoclonal antibody that inhibits IL-17A, was granted to include two new indications - the treatment of adult patients with active psoriatic arthritis and active ankylosing spondylitis. US FDA
Adalimumab-atto for SC injection
Amjevita™
Amgen Inc.
The first biosimilar to adalimumab (Humira®), Amjevita™ was approved to treat seven inflammatory diseases, including psoriatic arthritis and moderate-to-severe chronic plaque psoriasis. US FDA
Etanercept-szzs for SC injection
Erelzi™
Sandoz Inc., a Novartis division
Erelzi™ (etanercept-szzs), a tumor necrosis factor blocker biosimilar to etanercept (Enbrel®) was approved for all indications included in the reference product label. US FDA
Biosimilar of infliximab
Flixabi®
Samsung Bioepis Co.
Flixabi® (also known as SB2), an infliximab biosimilar referencing Remicade®, was approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn's disease, ulcerative colitis, and ankylosing spondylitis. European Commission
Infliximab-dyyb for IV infusion
Inflectra™
Hospira/Celltrion
Multiple indications were approved for Inflectra™, a biosimilar to infliximab (Remicade®). Approved uses include chronic severe plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. US FDA
Urticaria Bilastine 20 mg tablet
Blexten™
Aralez Pharmaceuticals
Bilastine 20 mg oral tablet was approved for the treatment of symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (such as itchiness and hives). This is the first new antihistamine introduced in Canada in over 15 years. Health Canada

In this issue:

  1. Tofacitinib in the Treatment of Rheumatoid Arthritis and Chronic Plaque Psoriasis
  2. A Review of Guselkumab, an IL-23 Inhibitor, for Moderate-to-Severe Plaque Psoriasis
  3. Skin Treatments Introduced in 2016
  4. Update on Drugs and Drug News - March-April 2017