Skin Treatments Introduced in 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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