Skin treatments introduced in 2018, categorized by type/class of therapy below:
Anti-acne Agent
Sarecycline hydrochloride tablets
Trade Name: Seysara™
Company: Paratek/Almirall
Indication/Description: Sarecycline was approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients years of age. Sarecycline is a new first-in-class, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
Approving Regulatory Agency: US FDA
Tretinoin 0.05% lotion
Trade Name: Altreno™
Company: Ortho Dermatologics
Indication/Description: Tretinoin 0.05% lotion was approved for the topical treatment of acne vulgaris in patients ≥9 years of age. This is the first formulation of tretinoin in a lotion; it includes hyaluronic acid, glycerin and collagen for enhanced moisturization.
Approving Regulatory Agency: US FDA
Antibiotic Agents
Dalbavancin hydrochloride for IV infusion
Trade Name: Xydalba™
Company: Cipher Pharmaceuticals
Indication/Description: This single-dose IV antibiotic was approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Xydalba™ is the first bactericidal, single-dose IV therapy effective against resistant bacteria such as methicillin-resistant Staphylococcus aureus causing skin and soft tissue infections, including cellulitis/erysipelas, major cutaneous abscesses, and wound infections.
Approving Regulatory Agency: Health Canada
Omadacycline for IV and oral use
Trade Name: Nuzyra™
Company: Paratek Pharmaceuticals
Indication/Description: Omadacycline, a tetracycline antibiotic, was approved for the treatment of adults with community-acquired bacterial pneumonia and ABSSSI. This modernized tetracycline is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical bacteria, and drug resistant strains.
Approving Regulatory Agency: US FDA
Anti-cancer Agents
Binimetinib + encorafenib
Company: Array BioPharmaIndication/Description: These kinase inhibitors were approved for oral combination treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a FDA-approved test. Binimetinib (a small molecule MEK inhibitor) + encorafenib (a small molecule BRAF inhibitor) in combination is the first targeted treatment to demonstrate over 30 months median overall survival.Approving Regulatory Agency: US FDA
Brentuximab vedotin for IV use
Company: Seattle Genetics, Inc. Takeda PharmaceuticalIndication/Description: Extension of current conditional marketing authorization was granted for brentuximab vedotin to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non- Hodgkin lymphoma, including CTCL.Approving Regulatory Agency: European Commission
Cemiplimab-rwlc for IV use
Trade Name: Libtayo®
Company: Regeneron/Sanofi
Indication/Description: This fully-human monoclonal antibody was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Cemiplimab-rwlc targets the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved for advanced CSCC in the US.
Approving Regulatory Agency: US FDA
Dabrafenib + trametinib in combination
Trade Name: Tafinlar® + Mekinist®
Company: Novartis
Indication/Description: This oral regimen of dabrafenib in combination with trametinib was approved for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutation, as detected by a FDA-approved test, and involvement of lymph node(s), following complete resection. Adjuvant therapy may be recommended for patients with melanoma at high-risk of recurrence after surgical resection
Approving Regulatory Agency: US FDA
Ipilimumab for IV use
Trade Name: Yervoy®
Company: Bristol-Myers Squibb Co.
Indication/Description: The indication of ipilimumab was explanded to include treatment of advanced (unresectable or metastatic) melanoma in pediatric patients ≥12 years of age. This is the first and only immuno-oncology agent to receive approval in the European Union in this patient population.
Approving Regulatory Agency: European Commission
Mogamulizumab-kpkc for IV infusion
Trade Name: Poteligeo®
Company: Kyowa Hakko Kirin Co.
Indication/Description: Mogamulizumab-kpkc was approved for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Poteligeo® is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain blood cancers including CTCL.
Approving Regulatory Agency: US FDA
Pembrolizumab for IV use
Trade Name: Keytruda®
Company: Merck & Co.
Indication/Description: An expanded indication was granted to pembrolizumab, an anti-PD-1 immunotherapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
Approving Regulatory Agency: US FDA
Antiviral Agent
HPV 9-valent vaccine, recombinant
Trade Name: Gardasil®9
Company: Merck, Sharp & Dohme
Indication/Description: A supplemental application for Gardasil®9 (human papillomavirus [HPV] 9-valent vaccine, recombinant) was granted approval, expanding the use of this vaccine to include women and men aged 27 through 45 years. Previously, the vaccine was only indicated in people aged 9 through 26 years.
Approving Regulatory Agency: US FDA
Tecovirimat capsule
Trade Name: Tpoxx®
Company: SIGA Technologies
Indication/Description: Tecovirimat, an orthopoxvirus-specific antiviral, was approved for the treatment of human smallpox disease caused by the variola virus. This is the first approved treatment for smallpox, a disease that at one time was thought to have been eradicated, but due to the threat of bioterrorism has become a heightened global concern.
Approving Regulatory Agency: US FDA
Atopic Dermatitis
Crisaborole 2% ointment
Trade Name: Eucrisa™
Company: Pfizer
Indication/Description: Crisaborole ointment was approved to treat mild-to-moderate eczema (atopic dermatitis) in patients ≥2 years of age. Cisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor for topical twice-daily use.
Approving Regulatory Agency: Health Canada
Dermal Fillers
Hyaluronic acid (HA) dermal filler
Trade Name: Restylane® Lyft
Company: Galderma Laboratories
Indication/Description: This HA-based dermal filler was approved for the correction of agerelated volume loss in the back of the hands for patients >21 years of age. Restylane® Lyft is the first and only HA injectable gel to be FDAapproved for restoring fullness to the back of the hands.
Approving Regulatory Agency: US FDA
HA dermal filler
Trade Name: Restylane® Lyft
Company: Galderma Laboratories
Indication/Description: Restylane® Lyft for use with a small blunt tip cannula was approved for cheek augmentation and the correction of age-related midface contour deficiencies in patients >21 years of age.
Approving Regulatory Agency: US FDA
Fabry Disease
Migalastat capsule
Trade Name: Galafold™
Company: Amicus Therapeutics
Indication/Description: Migalastat was approved as the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for use in adults who have a genetic mutation determined to be responsive to therapy based on laboratory data. This first-in-class chaperone treatment is designed to restore alpha-gal A activity in patients with amenable mutations.
Approving Regulatory Agency: US FDA
Hereditary Angioedema
Lanadelumab-flyo for SC injection
Trade Name: Takhzyro™
Company: Shire
Indication/Description: Lanadelumab-flyo injection was approved to prevent attacks of types I and II hereditary angioedema in people ≥12 years of age. Takhzyro™ is a monoclonal antibody that targets inhibition of plasma kallikrein.
Approving Regulatory Agency: Health Canada and US FDA
Hidradenitis Suppurativa
Biosimilar to adalimumab for SC use
Trade Name: Hadlima™
Company: Samsung Bioepis/Merck
Indication/Description: Approval was granted to Hadlima™ on the basis of similarity with the reference biologic drug Humira® for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and uveitis.
Approving Regulatory Agency: Health Canada
Hyperhidrosis
Glycopyrronium tosylate 2.4% cloth
Trade Name: Qbrexza™
Company: Dermira
Indication/Description: Glycopyrronium topical wipes were approved for the treatment of primary axillary hyperhidrosis in adult and pediatric patients ≥9 years of age. Qbrexza™ comes in single-use, pre-moistened, medicated cloths.
Approving Regulatory Agency: US FDA
Neurotoxin
PrabotulinumtoxinA
Trade Name: Nuceiva®
Company: Evolus/Clarion Medical
Indication/Description: This 900 kDa purified botulinum toxin type A complex was approved for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients <65 years of age.
Approving Regulatory Agency: Health Canada
Pemphigus Vulgaris
Rituximab for IV use
Trade Name: Rituxan®
Company: Genentech
Indication/Description: This CD20-directed cytolytic antibody was approved for treating adults with moderate-to-severe pemphigus vulgaris (PV). This approval marks the first biologic approved for PV and the first major therapeutic advance for this disease in more than 60 years.
Approving Regulatory Agency: US FDA
Postherpetic Neuralgia
Lidocaine topical system 1.8% for PHN
Trade Name: ZTlido™
Company: Sorrento/Scilex
Indication/Description: This transdermal anesthetic formulation was approved for the treatment of nerve pain associated with an outbreak of shingles, postherpetic neuralgia (PHN). The medicated patch uses a proprietary adhesion technology and is covered with a 1.8% dosing of lidocaine.
Approving Regulatory Agency: US FDA
Psoriasis
Adalimumab-adaz for SC injection
Trade Name: Hyrimoz™
Company: Sandoz/Novartis
Indication/Description: Marketing authorization was granted for this biosimilar to Humira® (adalimumab) to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Approving Regulatory Agency: US FDA
Biosimilar to adalimumab for SC injection
Trade Name: Hadlima™
Company: Samsung Bioepis/Merck
Indication/Description: Regulatory approval was granted to Hadlima™ on the basis of similarity with the reference biologic drug Humira® for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and uveitis.
Approving Regulatory Agency: Health Canada
Brodalumab for SC use
Trade Name: Siliq™
Company: Valeant
Indication/Description: This monoclonal antibody that targets the IL-17 receptor was approved for treating moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Approving Regulatory Agency: Health Canada
Certolizumab pegol for SC injection
Trade Name: Cimzia®
Company: UCB
Indication/Description: A label extension was granted for certolizumab pegol to include a new indication for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Certolizumab pegol is a monoclonal antibody directed against TNF-α.
Approving Regulatory Agency: US FDA
Halobetasol propionate 0.01% lotion
Trade Name: Bryhali™
Company: Ortho Dermatologics
Indication/Description: This new formulation of halobetasol propionate received approval for the topical treatment of plaque psoriasis in adult patients. Bryhali™ is a potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to 8 weeks.
Approving Regulatory Agency: US FDA
Ixekizumab for SC injection
Trade Name: Taltz®
Company: Eli Lilly and Company
Indication/Description: A label update for ixekizumab, a humanized monoclonal antiinterleukin- 17A (IL-17A) antibody, was approved to include data in psoriasis involving the genital area. The approved label update is based on results from a Phase 3b study that demonstrated significant improvement in the severity of psoriasis affecting the genital area.
Approving Regulatory Agency: US FDA
Secukinumab for SC injection
Trade Name: Cosentyx®
Company: Novartis
Indication/Description: A label update for this fully human IL-17A antagonist included the treatment for moderate-to-severe scalp psoriasis. The regulatory decision was based on data from the Phase 3 SCALP trial that showed 56.9% of the IL-17A inhibitor group achieved a score of clear or almost clear vs. 5.9% in the placebo group.
Approving Regulatory Agency: US FDA
Tildrakizumab-asmn for SC injection
Trade Name: Ilumya™
Company: Sun Pharmaceutical
Indication/Description: Tildrakizumab was approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This humanized IgG1 monoclonal antibody selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines.
Approving Regulatory Agency: US FDA
Psoriatic Arthritis
Adalimumab-adaz for SC injection
Trade Name: Hyrimoz™
Company: Sandoz/Novartis
Indication/Description: Marketing authorization was granted for Hyrimoz™, a biosimilar to Humira® (adalimumab), as an approved treatment for multiple chronic inflammatory diseases, including psoriatic arthritis and plaque psoriasis. This drug will not be commercially available in the US until September 30, 2023.
Approving Regulatory Agency: US FDA
Biosimilar to adalimumab for SC injection
Trade Name: Hadlima™
Company: Samsung Bioepis/Merck
Indication/Description: Regulatory approval was granted to Hadlima™ on the basis of similarity with the reference biologic drug Humira® for treating multiple chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Secukinumab for SC injection
Trade Name: Consentyx®
Company: Novartis
Indication/Description: New data was approved for inclusion in secukinumab’s prescribing information, demonstrating the IL-17A inhibitor significantly slows the progression of joint structural damage at Week 24 vs. placebo in patients with active psoriatic arthritis.
Approving Regulatory Agency: US FDA
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