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 |
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| 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 |
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| 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 |
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| 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 |
