Skin treatments introduced in 2019, categorized by type/class of therapy below:
Anti-acne Agent
Dapsone gel
Trade Name: Aczone®
Company: Almirall
Indication/Description: An expanded indication for dapsone 7.5% gel was approved to include patients aged 9-11 years for the treatment of inflammatory and non-inflammatory acne.
Approving Regulatory Agency: US FDA
Trifarotene cream
Trade Name: Aklief®
Company: Galderma
Indication/Description: Approval was granted to trifarotene 0.005% cream for the topical treatment of acne vulgaris. Trifarotene is the first new retinoid molecule to receive approval for the treatment of acne in more than 20 years.
Approving Regulatory Agency: Health Canada, US FDA
Minocycline foam
Trade Name: Amzeeq™
Company: Foamix
Indication/Description: Minocycline 4% topical foam was approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years of age.
Approving Regulatory Agency: US FDA
Tazarotene lotion
Trade Name: Arazlo™
Company: Ortho Dermatologics/Bausch Health
Indication/Description: This new preparation of tazarotene was approved for the topical treatment of acne vulgaris in patients ≥9 years of age. Tazarotene lotion 0.045% is the first tazarotene acne treatment available in a lotion form.
Approving Regulatory Agency: US FDA
Anti-cancer Agents
Pembrolizumab
Trade Name: Keytruda®
Company: Merck & Co.
Indication/Description: An expanded indication was granted to pembrolizumab, 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
Pembrolizumab
Trade Name: Keytruda®
Company: Merck & Co.
Indication/Description: An additional indication was granted for pembrolizumab for the adjuvant treatment of patients with high-risk stage III melanoma with lymph node involvement following complete resection.
Approving Regulatory Agency: US FDA
Tazemetostat tablets
Trade Name: Tazverik™
Company: Epizyme
Indication/Description: Accelerated approval of tazemetostat was granted for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Approving Regulatory Agency: US FDA
Atopic Dermatitis
Dupilumab
Trade Name: Dupixent®
Company: Sanofi/Regeneron
Indication/Description: An expanded indication was granted for this fully human monoclonal antibody inhibitor of interleukin (IL)-4 and IL-13 to treat adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
Approving Regulatory Agency: European Commission, US FDA
Behçet’s Disease
Apremilast tablets
Trade Name: Otezla®
Company: Celgene
Indication/Description: An expanded label was approved for apremilast to include the treatment of oral ulcers associated with Behçet’s Disease, making this the drug’s third indication in addition to plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Dermal Filler
HA dermal filler
Trade Name: Juvéderm Voluma® XC
Company: Allergan
Indication/Description: This injectable hyaluronic acid (HA) gel dermal filler was approved for use with a TSK STERiGLIDE™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults aged >21 years.
Approving Regulatory Agency: US FDA
Erythropoietic Protoporphyria
Afamelanotide implant
Trade Name: Scenesse®
Company: Clinuvel
Indication/Description: This selective agonist of the melanocortin 1 receptor was approved for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria.
Approving Regulatory Agency: US FDA
Graft-versus-Host Disease
Ruxolitinib tablets
Trade Name: Jakafi®
Company: Incyte
Indication/Description: An additional indication was approved for ruxolitinib (a first-in-class JAK1/JAK2 inhibitor) for treating steroid-refractory acute graftversus- host disease in patients ≥12 years of age.
Approving Regulatory Agency: US FDA
Granulomatosis with Polyangiitis
Rituximab
Trade Name: Rituxan®
Company: Genentech
Indication/Description: The approved uses of this CD20-directed cytolytic antibody were expanded to include treatment of adult patients with granulomatosis with polyangiitis and microscopic polyangiitis in children ≥2 years of age in combination with glucocorticoids.
Approving Regulatory Agency: US FDA
Neurotoxin
PrabotulinumtoxinA-xvfs
Trade Name: Jeuveau™
Company: Evolus
Indication/Description: PrabotulinumtoxinA, a 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: US FDA
Psoriasis
Adalimumab-afzb
Trade Name: Abrilada™
Company: Pfizer
Indication/Description: This biosimilar to Humira® (adalimumab) was approved for the treatment of multiple chronic inflammatory diseases, including psoriatic arthritis and plaque psoriasis.
Approving Regulatory Agency: US FDA
Infliximab-axxq
Trade Name: Avsola™
Company: Amgen
Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, Remicade® (infliximab), including chronic severe plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Halobetasol propionate + tazarotene lotion
Trade Name: Duobrii™
Company: Bausch Health
Indication/Description: This combination of halobetasol propionate 0.01 (corticosteroid) and tazarotene 0.045% (retinoid) in a lotion formulation was approved for the topical treatment of plaque psoriasis in adults.
Approving Regulatory Agency: US FDA
Calcipotriene + betamethasone dipropionate
Trade Name: Enstilar® foam Taclonex® topical suspension
Company: Leo Pharma
Indication/Description:A label expansion was approved for Enstilar® foam for the topical treatment of plaque psoriasis to include patients aged ≥12 years. Additionally, Taclonex® topical suspension was approved for the treatment of scalp and body plaque psoriasis in patients aged ≥12 years.
Approving Regulatory Agency: US FDA
Etanercept-ykro
Trade Name: Eticovo™
Company: Samsung Bioepis
Indication/Description:This biosimilar referencing etanercept (Enbrel®) was approved across all eligible indications including plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Adalimumab-bwwd
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 the treatment of multiple indications including plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Risankizumab
Trade Name: Skyrizi™
Company: AbbVie
Indication/Description: Approval was granted to risankizumab, an interleukin-23 inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (European Commission, Health Canada and FDA). In Japan, approved indications include plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis.
Approving Regulatory Agency: European Commission, Health Canada, MHLW (Japan), US FDA
Psoriatic Arthritis
Adalimumab-afzb
Trade Name: Abrilada™
Company: Pfizer
Indication/Description: This biosimilar to Humira® (adalimumab) was approved for the treatment of multiple chronic inflammatory diseases, including psoriatic arthritis and plaque psoriasis.
Approving Regulatory Agency: US FDA
IzumabInfliximab-axxq
Trade Name: Avsola™
Company: Amgen
Indication/Description:This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, Remicade® (infliximab), including chronic severe plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Etanercept-ykro
Trade Name: Eticovo™
Company: Samsung Bioepis
Indication/Description: This biosimilar referencing etanercept (Enbrel®) was approved across all eligible indications including plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Biosimilar to adalimumab
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 the treatment of multiple indications including plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: US FDA
Risankizumab
Trade Name: Skyrizi™
Company: AbbVie
Indication/Description: Approval was granted to risankizumab, an interleukin-23 inhibitor, for the treatment of psoriatic arthritis and three types of psoriasis.
Approving Regulatory Agency: MHLW
Systemic Lupus Erythematosus
Belimumab for IV use
Trade Name: Benlysta®
Company: GSK
Indication/Description: An expanded label was grant for belimumab to include use in children with lupus. The approval extends the current indication in the US for IV Benlysta® in adults, to patients aged ≥5 years of age with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy.
Approving Regulatory Agency: US FDA
Urticaria
Cetirizine hydrochloride for IV injection
Trade Name: Quzyttir™
Company: TerSera
Indication/Description: Cetirizine hydrochloride injection was approved for the treatment of acute urticaria in patients ≥6 months of age. This is the first IV formulation of the histamine-1 receptor antagonist cetirizine.
Approving Regulatory Agency: US FDA
Vaccine
Smallpox and monkeypox vaccine, live, attenuated, non-replicating (MVA-BN®, liquid-frozen)
Trade Name: Jynneos™
Company: Bavarian Nordic
Indication/Description: Approval was granted to Jynneos™ for prevention of smallpox and monkeypox disease in adults aged ≥18 years determined to be at high risk for smallpox or monkeypox infection. This is the only approved non-replicating smallpox vaccine in the US and the only approved monkeypox vaccine worldwide.
Approving Regulatory Agency: US FDA
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, and is sourced from both regulatory and industry news releases.
