Skin Treatments Introduced in 2015
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Skin Treatments Introduced in 2015

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Type/Class of Therapy Generic/Trade/ Company Names Indication Approving Regulatory Agency
Adipolytic Agent Deoxycholic acid injection
Belkyra™ (Canada)
Kybella™ (US)
Kythera Biopharmaceuticals
This first-in-class adipolytic agent was approved for treating moderate to severe submental fat. Deoxycholic acid (ATX- 101) is indicated for the reduction of submental fat, which commonly presents as a double chin. Health Canada
US FDA
Actinic Keratosis 5-fluorouracil 0.5% + salicylic acid 10% solution
Actikerall™
Cipher Pharmaceuticals
This topical antineoplastic agent was approved for the treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (Grade I/II) of the face, forehead and balding scalp in immunocompetent adult patients. Health Canada
Anti-acne Agents Adapalene 0.3% + benzoyl peroxide 2.5% gel
Epiduo® Forte(US)
Tactupump Forte™ (Canada)
Galderma
Fixed combination adapalene 0.3% and benzoyl peroxide 2.5% gel was approved for the once-daily, topical treatment of acne vulgaris. This preparation is the first combination of these strengths of adapalene and benzoyl peroxide. Health Canada
US FDA
Antibacterial Agents Dalbavancin IV injection
Dalvance™
Durata Therapeutics
Dalbavancin, a novel second generation lipoglycopeptide antibiotic, was approved for the treatment of adults with skin infections. Treatment is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. European Commission (EU)
Tedizolid phosphate tablets and IV injection
Sivextro™
Cubist Pharmaceuticals
Tedizolid, a novel oxazolidinone-class antibacterial agent, was approved for the treatment of adult ABSSSI caused by susceptible Gram-positive bacteria, including methicillin- resistant Staphylococcus aureus (MRSA). Health Canada
Anti-cancer Agents Cobimetinib + vemurafenib
Cotellic™ + Zelboraf®
Daiichi Sankyo Group
Exelixis
Genetech (Roche Group)
Approval was granted to cobimetinib (MEK-inhibitor) for use in combination with vemurafenib (BRAF-inhibitor) as an oral treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. European Commission
Swissmedic (Switzerland)
US FDA
Dabrafenib + trametinib
Tafinlar® + Mekinist®
Novartis AG
Combination therapy with dabrafenib (Tafinlar®) + trametinib (Mekinist®) was approved to treat patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. US FDA
Ipilimumab IV injection
Yervoy®
Bristol-Myers Squibb
This immune checkpoint inhibitor was approved for the additional indication of adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of >1 mm (Stage III) who have undergone complete resection including total lymphadenectomy. US FDA
Nivolumab IV infusion
Opdivo®
Bristol-Myers Squibb
This human programmed death receptor-1 (PD-1) blocking monoclonal antibody was approved to treat previously untreated cases of BRAF V600 wild-type unresectable or metastatic melanoma in adults. European Commission
Health Canada
Nivolumab + ipilimumab
Opdivo® + Yervoy®
Bristol-Myers Squibb Company
Nivolumab in combination with ipilimumab was approved for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. US FDA
Pembrolizumab IV injection
Keytruda®
Merck & Co., Inc.
Pembrolizumab was approved for the treatment of unresectable or metastatic melanoma as first-line therapy and/or for previously treated patients. In December 2015, the FDA approved an expanded indication for pembrolizumab to include the first-line treatment of patients with advanced melanoma. European Commission
Health Canada
MHRA (UK)
US FDA
Sonidegib phosphate capsules
Odomzo®
Novartis Pharmaceuticals
Sonidegib received approval to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. US FDA
Talimogene laherparepvec (T-Vec) oncolytic virus therapy
Imlygic™
BioVex Inc/Amgen Inc.
The first viral-based cancer therapeutic was approved for treating melanoma lesions in the skin and lymph nodes that cannot be removed completely by surgery. Derived from HSV type 1 (cold sore virus), Imlygic® has been modified to replicate within tumors and produce the immune stimulatory protein human GM-CSF, resulting in the death of tumor cells through an anti-tumor immune response. European Commission
US FDA
Antiviral Agent Human papillomavirus 9-valent vaccine, recombinant
Gardasil®9
Merck
This vaccine was approved for use in females 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL®9 is also approved for use in boys 9 to 15 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. GARDASIL®9 includes the greatest number of HPV types in any available HPV vaccine. It was FDA-approved in 2014 for use in boys 9 to 15 years of age for the prevention of these diseases. The FDA approved an expanded age indication for GARDASIL®9 in December 2015 to include use in males 16 through 26 years of age. Health Canada
US FDA
Dermal Fillers Dermal filler with calcium hydroxylapatite (CaHA) + integral 0.3% lidocaine
Radiesse® (+)
Merz
Approval was granted to Radiesse® (+), an injectable implant dermal filler that contains a small quantity of the local anesthetic lidocaine. Radiesse® (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Health Canada
US FDA
Dermal filler with calcium hydroxylapatite (CaHA)
Radiesse®
Merz North America
This dermal filler was approved for hand augmentation to correct volume loss in the dorsum of the hands. Treatment provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins. US FDA
Hyaluronic acid (HA) filler
Juvederm® Ultra XC
Allergan plc
Marketing approval was granted to this HA-based dermal filler for injection into the lips and perioral area for lip augmentation in adults >21 years of age. US FDA
HA gel injectable dermal filler
Restylane® Lyft with Lidocaine
Galderma
Market approval was granted to this injectable gel to increase volume and smooth wrinkles in the face of patients aged >21 years. Restylane® Lyft was formerly marketed as Perlane-L®. US FDA
Polymethylmethacrylate collagen dermal filler
Bellafill®
Suneva Medical, Inc.
Approval was granted to this dermal filler for the treatment of acne scars. Bellafill® is the only filler indicated for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients >21 years of age. US FDA
Hidradenitis Suppurativa Adalimumab SC injection
Humira®
AbbVie Inc.
Approval was granted to this tumor necrosis factor-alpha (TNF-α) inhibitor for the treatment of moderate to severe hidradenitis suppurativa (acne inversa). European Commission
US FDA
Psoriasis Betamethasone valerate 0.1% patch
Beteflam™
Cipher Pharmaceuticals
The Beteflam™ Patch is a novel, self-adhesive medicated plaster, containing 0.1% betamethasone valerate, approved for the treatment of inflammatory skin conditions such as chronic plaque psoriasis. Health Canada
Calcipotriene 0.005% + betamethasone dipropionate 0.064% foam
Enstilar®
LEO Pharma Inc.
A foam containing a fixed combination of calcipotriene and betamethasone dipropionate was approved for the topical treatment of plaque psoriasis in adults 18 years of age and older. This once-daily, alcohol-free foam formulation in a pressurized spray allows application across large body areas of plaque psoriasis. US FDA
Secukinumab SC injection
Consentyx™
Novartis Pharmaceuticals
Approval was granted to secukinumab for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, or a combination of both. Secukinumab is a fully human monoclonal antibody that inhibits the proinflammatory cytokine interleukin 17A (IL-17A). Health Canada
European Commission
US FDA
Psoriatic Arthritis Apremilast tablets
Otezla®
Celgene Corporation
An expanded indication for psoriatic arthritis was granted to apremilast, an oral phosphodiesterase-4 inhibitor, which was initially approved in November 2014 for moderate to severe plaque psoriasis. Health Canada
Rosacea Azelaic acid 15% foam
Finacea® Foam
Bayer HealthCare
Azelaic acid 15% foam was approved for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. US FDA
Ivermectin 1% cream
Rosiver®
Galderma Canada Inc.
Ivermectin 1% cream was approved for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. Ivermectin has both anti-inflammatory and antiparasitic effects. Health Canada
Varicose Veins Polidocanol 1% injectable foam
Varithena®
BTG plc
Polidocanol injectable foam was approved for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system, above and below the knee. Health Canada
Varicose vein procedure with n-butyl-2-cyanoacrylate adhesive polymer
VenaSeal™ Closure System
Covidien LLC/Medtronic
Approval was granted to the first adhesive varicose vein treatment. VenaSeal™ closure system is the only non- tumescent, non-thermal, non-sclerosant procedure to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. US FDA

In this issue:

  1. Dupilumab, A Monoclonal Antibody for Atopic Dermatitis: A Review of Current Literature
  2. Nivolumab for Metastatic Melanoma
  3. Skin Treatments Introduced in 2015
  4. Update on Drugs and Drug News - March-April 2016