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Skin Treatments Introduced in 2014

Type/Class of Therapy Generic/Trade/ Company Names Indication Approving Regulatory Agency
Anti-acne Agents Clindamycin phosphate 1.2% + benzoyl peroxide 3.75% gel
Onexton™
Valeant Pharmaceuticals
Approval was granted to this once-daily topical treatment of comedonal (noninflammatory) and inflammatory acne. This fixed combination of a lincosamide antibacterial agent and an antimicrobial is indicated for the treatment of acne vulgaris in patients ≥12 years of age. US FDA
Doxycycline hyclate tablets
Acticlate™
Aqua Pharmaceuticals Almirall
This tetracycline-class antimicrobial agent was approved for treating a number of infections including adjunctive therapy in severe acne. Several dosing options are available with film-coated round 75 mg tablets and oval-shaped dual-scored 150 mg tablets. US FDA
Tretinoin gel microsphere 0.08%
Retin-A Micro®
Valeant Pharmaceuticals
Approval of a Supplemental New Drug Application (sNDA) was granted for Retin-A Micro® gel microsphere 0.08% for the topical treatment of acne vulgaris. Retin-A Micro® gel is already available in 0.04% and 0.1% strengths. US FDA
Actinic Keratosis 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, such as Staphylococcus aureus (including methicillin-susceptible and methicillin resistant strains) and Streptococcus pyogenes. US FDA
Dalbavancin IV injection
Orbactiv™
The Medicines Company
Approval was granted for this novel semi-synthetic glycopeptide antibiotic for treating adults with ABSSSI caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin resistant strains), various Streptococcus species and Enterococcus faecalis. US FDA
Tedizolid phosphate tablets & 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). US FDA
Metronidazole 1.3% vaginal gel
Actavis plc
Valeant Pharmaceuticals
A New Drug Application (NDA) for metronidazole 1.3% vaginal gel, a nitroimidazole antibiotic, was approved for the treatment of bacterial vaginosis (BV) in non-pregnant women. This preparation of metronidazole offers a convenient single-dose treatment for BV that is packaged in a pre-filled disposable applicator. US FDA
Antifungal Agents Efinaconazole 10% topical solution
Jublia®
Valeant Pharmaceuticals
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). US FDA
Naftifine HCl 2% gel & cream
Naftin®
Merz Dermatology
Naftin® (naftifine HCl) 2% gel and cream formulations received approval for the treatment of interdigital type tinea pedis in pediatric patients aged 12-17 years. This pediatric approval expands the previous labelling that indicated use in patients >18 years of age. US FDA
Tavaborole 5% topical solution
Kerydin™
Anacor Pharmaceuticals
Tavaborole, the first oxaborole antifungal agent, was approved for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes. This clear, colorless, alcohol-based solution is applied with a dropper to the infected toenail once daily for 48 weeks. US FDA
Antiparasitic Agent Miltefosine capsules
Impavido®
Paladin Labs Inc.
Knight Therapeutics Inc.
Approval was granted to this oral alkylphosphocholine antiparasitic agent for the treatment of three main types of leishmaniasis: visceral leishmaniasis (affects internal organs), cutaneous leishmaniasis (affects the skin) and mucosal leishmaniasis (affects the nose and throat). It is intended for use in patients ≥12 years of age. Impavido® is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis. US FDA
Antiviral Agent Human papillomavirus 9-valent vaccine, recombinant
Gardasil®9
Merck
This 9-valent human papillomavirus (HPV) vaccine was approved for use in girls and young women 9-26 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 9-15 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. US FDA
Dermal Filler Hyaluronic acid-based dermal filler
Restylane® Silk
Valeant Pharmaceuticals
(In July 2014, all rights to Restylane® were sold by Valeant to Galderma)
Marketing clearance was granted for Restylane® Silk injectable gel with 0.3% lidocaine, a device indicated for submucosal implantation for lip augmentation and dermal implantation for the correction of perioral rhytids in patients >21 years of age. US FDA
Dupuytren's Contracture Collagenase clostridium histolyticum for injection
Xiaflex®
Auxilium Pharmaceuticals BioSpecifics
A supplemental Biologics License Application (sBLA) was approved for this novel, first-in-class biologic for the treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit. Xiaflex® obtained FDA approval in 2010 as the first and only nonsurgical treatment for adult Dupuytren's contracture patients with a palpable cord in the palm. US FDA
Hemangioma Propranolol hydrochloride oral solution
Hemangeol™
Pierre Fabre Dermatologie
The first and only beta-blocker formulation was approved for the treatment of proliferating infantile hemangioma requiring systemic therapy. Hemangeol™, specifically developed for use in pediatric patients, was studied in infants aged 5 weeks to 5 months (at therapy initiation). The treatment protocol of 3 mg/kg/day for 6 months demonstrated a 60.4% success rate vs. 3.6% in the placebo group, achieving the primary endpoint of complete or nearly-complete resolution. US FDA
Hereditary Angioedema C1 esterase inhibitor IV infusion
Ruconest®
Pharming Group NV
Salix Pharmaceuticals
The first recombinant human C1 esterase inhibitor was approved for the treatment of acute angioedema attacks in adult and adolescent patients with acute hereditary angioedema (HAE). US FDA
Ecallantide SC injection
Kalbitor®
Dyax Corp.
Ecallantide, a peptide inhibitor of plasma kallikrein, was approved for the treatment of HAE attacks. This drug is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients ≥12 years of age. US FDA
Icatibant SC injection
Firazyr®
Shire Canada
A Notice of Compliance was issued for icatibant acetate ready-to-use injection for the treatment of acute attacks of HAE in adults with C1-esterase inhibitor deficiency via blockade of bradykinin at the bradykinin B2 receptor. Health Canada
Melanoma Trametinib tablet + Dabrafenib capsule
Mekinist® + Tafinlar®
GlaxoSmithKline plc
Accelerated approval was granted to trametinib in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by the FDA-approved THxID™ BRAF test. Approval of the combination therapy is based on the demonstration of response rate and median duration of response in a multicenter, open-label, randomized, active-controlled, dose-ranging Phase 1/2 trial, which compared combination trametinib and dabrafenib to dabrafenib monotherapy. The overall response rate was 76% (95% confidence interval [CI]; 62, 87) with combination therapy compared to 54% (95% CI; 40, 67) with dabrafenib alone. US FDA
Nivolumab IV infusion
Opdivo®
Ono Pharmaceutical Co.
Manufacturing and marketing approval was granted to this programmed death-1 (PD-1) monoclonal antibody for the treatment of unresectable melanoma. It is the first PD-1 immune checkpoint inhibitor to gain regulatory approval. Opdivo® received accelerated US FDA approval in December 2014. MHWL (Japan)
US FDA
Pembrolizumab IV injection
Keytruda®
Merck & Co., Inc.
Accelerated approval was granted to pembrolizumab for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. The drug acts by targeting the PD-1 receptor. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with programmed cell death 1 ligand 1 (PD-L1) and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. US FDA
Photodermatosis Afamelanotide 16 mg SC bioresorbable implants
Scenesse®
Clinuvel Pharmaceuticals
The European Medicines Agency (EMA) approved afamelanotide 16 mg implants for treating the genetic disorder erythropoietic protoporphyria (EPP), a painful photodermatosis. This photoprotective agent belongs to a family of drugs known as melanocortins and is the first ever treatment developed for EPP. Afamelanotide provides prophylactic treatment through its antioxidant effects and activation of melanin in skin, thereby providing patients with a biological barrier between their skin and the various wavelengths of light that trigger phototoxic reactions. European Commission
Psoriasis Apremilast tablets
Otezla®
Celgene Corporation
This orally available, first-in-class, small molecule inhibitor of phosphodiesterase-4 (PDE4) was approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Inhibition of PDE4 suppresses both TNF-α production and immune responses, which play important roles in the chronic inflammation associated with the development of skin symptoms in psoriasis. US FDA
Health Canada
Calcipotriene 0.005% + betamethasone dipropionate 0.064% topical suspension
Taclonex®
Leo Pharma Inc.
An expanded indication was granted for this topical combination treatment for plaque psoriasis of the scalp in patients 12-17 years of age. It is the first indication for adolescent patients aged ≥12 years with scalp plaque psoriasis among commercially available treatments. US FDA
Methotrexate SC injection
Rasuvo™
Medac Pharma
Approval was granted to this SC injectable methotrexate therapy delivered in an auto-injector for rheumatoid arthritis, polyarticularcourse juvenile idiopathic arthritis, and psoriasis. US FDA
Psoriatic Arthritis Apremilast tablets
Otezla®
Celgene Corporation
Approval was granted to the first oral therapy for the treatment of adults with active psoriatic arthritis (PsA). Apremilast is an oral small molecule inhibitor of PDE4 specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, thereby suppressing immune responses. US FDA
Rosacea European Commission:
Brimonidine 3 mg/g gel
Mirvaso®
Galderma International

Health Canada:
Brimonidine tartrate 0.33% topical gel
Onreltea®
Galderma Canada Inc.
This alpha-adrenergic receptor agonist received approval for the topical treatment of 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. This drug has a rapid onset of action, with effects occurring as quickly as 30 minutes after application and lasting up to 12 hours. Brimonidine tartrate 0.33% gel (Mirvaso®) was US FDA approved in August of 2013. European Commission
Health Canada
Ivermectin 1% cream
Soolantra®
Galderma Laboratories, L.P.
Ivermectin 1% cream was approved for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. The exact cause of rosacea is unknown, but multiple triggers have been implicated. Recent evidence suggests that rosacea may be caused by the over-proliferation of Demodex mites in the skin. Ivermectin has both anti-inflammatory and antiparasitic activities. US FDA
Urticaria Omalizumab SC injection
Xolair®
Genentech, Inc. Novartis
Omalizumab (a recombinant humanized monoclonal antibody that blocks the high-affinity Fc receptor of immunoglobulin E) was approved for the treatment of chronic idiopathic urticaria (CIU), also referred to as chronic spontaneous urticaria (CSU). The new use (already approved for asthma) is for patients ≥12 years of age who remain symptomatic despite H1-antihistamine therapy. Treatment is not indicated for other forms of urticaria (hives). European Commission
Health Canada
US FDA
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In this issue:

  1. Interleukin-23 in the Pathogenesis and Treatment of Psoriasis
  2. Male Aesthetics
  3. Skin Treatments Introduced in 2014
  4. Update on Drugs and Drug News - March-April 2015