Skin treatments introduced in 2020, categorized by type/class of therapy below:
Actinic Keratosis
Tirbanibulin ointment 1%
Trade Name: Klisyri®
Company: Almirall/Athenex
Indication/Description: This novel, first-in-class microtubule inhibitor was approved for the topical treatment of actinic keratosis of the face or scalp.
Approving Regulatory Agency: US FDA
Anti-Acne Agents
Clascoterone 1% cream
Trade Name: Winlevi®
Company: Cassiopea SpA
Indication/Description: Approval was granted to clascoterone (cortexolone 17α-propionate) 1% cream for treating acne vulgaris in patients aged ≥12 years. This is the first acne drug with a new mechanism of action to gain regulatory approval in the US in the last 40 years.
Approving Regulatory Agency: US FDA
Anti-Cancer Agents
Pembrolizumab for IV use
Trade Name: Keytruda®
Company: Merck & Co.
Indication/Description: An additional indication was granted for this programmed death receptor-1 (PD-1)-blocking antibody as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
Approving Regulatory Agency: US FDA
Pomalidomide capsules
Trade Name: Pomalyst®
Company: Bristol Myers Squibb
Indication/Description: An expanded indication for pomalidomide was granted to treat patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative. This is the only oral and first new therapeutic option for Kaposi sarcoma in more than 20 years.
Approving Regulatory Agency: US FDA
Sonidegib capsules
Trade Name: Odomzo®
Company: Sun Pharma
Indication/Description: Approval was granted to this oral antineoplastic agent (a hedgehog pathway inhibitor) for treating adult patients with histologically confirmed locally advanced basal cell carcinoma that is not amenable to radiation therapy or curative surgery.
Approving Regulatory Agency: Health Canada
Tazemetostat tablets
Trade Name: Tazverik™
Company: Epizyme, Inc.
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
Triplet melanoma therapy
Trade Name: Tecentriq® + Cotellic® and Zelboraf®
Company: Genentech
Indication/Description: This triplet regimen of atezolizumab (Tecentriq®, anti-PD-L1 antibody) + cobimetinib (Cotellic®, MEK inhibitor) and vemurafenib (Zelboraf®, BRAF kinase inhibitor) was approved for treating BRAF V600 mutation-positive advanced melanoma patients. This is the first FDA-approved combination for treating metastatic melanoma that brings together immunotherapy with targeted therapies.
Approving Regulatory Agency: US FDA
Atopic Dermatitis
Crisaborole ointment 2%
Trade Name: Eucrisa®
Company: Pfizer
Indication/Description: A supplemental new drug application was approved, expanding the indication of crisaborole to include treatment of mild-to-moderate atopic dermatitis in children ages 3 months to 24 months.
Approving Regulatory Agency: US FDA
Dupilumab SC use
Trade Name: Dupixent®
Company: Regeneron/Sanofi
Indication/Description: Dupilumab was approved for treating children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is the only biologic approved for this population.
Approving Regulatory Agency: US FDA
Autoinflammatory Disease
Anakinra SC use
Trade Name: Kineret®
Company: Swedish Orphan Biovitrum (Sobi™)
Indication/Description: The supplemental Biologics License Application for anakinra was approved for treating deficiency of IL-1 receptor antagonist (DIRA), an ultra-rare, autoinflammatory disease caused by a genetic mutation in the IL1RN gene, resulting in life-threatening systemic inflammation with skin and bone involvement.
Approving Regulatory Agency: US FDA
Cellulite
Collagenase clostridium histolyticum-aaes SC use
Trade Name: Qwo™
Company: Endo International
Indication/Description: Injectable collagenase clostridium histolyticum-aaes was approved for the treatment of moderate to severe cellulite in the buttocks of adult women.
Approving Regulatory Agency: US FDA
Dermal Fillers
HA injectable filler
Trade Name: Juvéderm® Voluma™ XC
Company: Allergan Aesthetics
Indication/Description: This hyaluronic acid (HA)-based dermal filler was approved for augmentation of the chin region to improve the chin profile in patients aged >21 years.
Approving Regulatory Agency: US FDA
HA injectable filler
Trade Name: Restylane® Kysse™
Company: Galderma
Indication/Description: Approval was granted to this preparation of HA-based dermal filler for lip augmentation and the correction of upper perioral rhytids in adults aged >21 years.
Approving Regulatory Agency: US FDA
Head Lice
Abametapir 0.74% lotion
Trade Name: Xeglyze™
Company: Dr. Reddy’s Laboratories
Indication/Description: Approval was granted to abametapir lotion for the topical treatment of head lice infestation in patients ≥6 months of age.
Approving Regulatory Agency: US FDA
Hereditary Angioedema
Berotralstat capsules
Trade Name: Orladeyo™
Company: BioCryst Pharmaceuticals
Indication/Description: Oral, once-daily berotralstat, a plasma kallikrein inhibitor, was approved for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged ≥12 years.
Approving Regulatory Agency: US FDA
C1 esterase inhibitor (human) SC use
Trade Name: Haegarda®
Company: CSL Behring
Indication/Description: An expanded pediatric indication was approved for Haegarda® for routine prophylaxis to prevent HAE attacks in patients aged ≥6 years.
Approving Regulatory Agency: US FDA
Hidradenitis Suppurativa
Adalimumab biosimilar SC use
Trade Name: Amgevita®
Company: Amgen Canada
Indication/Description: This biosimilar to adalimumab (Humira®) was approved for treating nine chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Adalimumab-fkjp SC use
Trade Name: Hulio®
Company: Viatris (Canada)/Mylan (US) Fujifilm Kyowa Kirin
Indication/Description: This biosimilar to adalimumab (Humira®) was approved for the treatment of multiple chronic diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada, US FDA
Adalimumab biosimilar SC use
Trade Name: Hyrimoz®
Company: Sandoz Canada
Indication/Description: Marketing authorization was granted to this tumor necrosis factor (TNF)-alpha blocker referencing adalimumab (Humira®) for treating the same nine indications, including psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada, US FDA
Adalimumab biosimilar SC use
Trade Name: Idacio®
Company: Fresenius Kabi
Indication/Description: This biosimilar referencing adalimumab (Humira®) was approved across all eligible indications, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Golimumab IV use
Trade Name: Simponi® Aria™
Company: Janssen Pharmaceutical
Indication/Description: Golimumab was approved for treating patients ≥2 years of age with active polyarticular juvenile idiopathic arthritis; this expanded indication also includes active psoriatic arthritis for this patient population.
Approving Regulatory Agency: US FDA
Guselkumab SC use
Trade Name: Tremfya®
Company: Janssen Pharmaceuticals
Indication/Description: An additional indication was approved for this IL-23 receptor inhibitor to treat adult patients with active psoriatic arthritis.
Approving Regulatory Agency: US FDA
Infliximab biosimilar IV use
Trade Name: Avsola™
Company: Amgen Canada
Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, infliximab (Remicade®), including chronic severe plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: Health Canada
Neurofibromatosis
Selumetinib capsules
Trade Name: Koselugo®
Company: AstraZeneca, Merck
Indication/Description: This inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) was approved for the treatment of pediatric patients aged
≥2 years with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). This is the first regulatory approval of a therapeutic agent to treat NF1 PN.
Approving Regulatory Agency: US FDA
Psoriasis
Adalimumab biosimilar SC use
Trade Name: Amgevita®
Company: Amgen Canada
Indication/Description: This biosimilar to adalimumab (Humira®) was approved for treating nine chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Adalimumab-fkjp SC use
Trade Name: Hulio®
Company: Viatris (Canada)/Mylan (US) Fujifilm Kyowa Kirin
Indication/Description: This biosimilar to adalimumab (Humira®) was approved for the treatment of multiple chronic diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada, US FDA
Adalimumab biosimilar SC use
Trade Name: Hyrimoz®
Company: Sandoz Canada
Indication/Description: Marketing authorization was granted to this TNF blocker referencing adalimumab (Humira®) for treating the same nine indications, including psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Adalimumab biosimilar SC use
Trade Name: Idacio®
Company: Fresenius Kabi
Indication/Description: This biosimilar referencing adalimumab (Humira®) was approved across all eligible indications including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Infliximab biosimilar IV use
Trade Name: Avsola™
Company: Amgen Canada
Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, infliximab (Remicade®), including chronic severe plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: Health Canada
Ustekinumab SC use
Trade Name: Stelara®
Company: Janssen Pharmaceuticals
Indication/Description: An expanded indication was approved for ustekinumab, an interleukin (IL)-12 and IL-23 inhibitor, for the treatment of pediatric patients (6 to 11 years of age) with moderate to severe plaque psoriasis.
Approving Regulatory Agency: US FDA
Calcipotriene + betamethasone dipropionate cream
Trade Name: Wynzora®
Company: MC2 Therapeutics
Indication/Description: This first cream-based fixed dose combination of calcipotriene + betamethasone dipropionate, w/w 0.005%/0.064%, was approved for the once-daily topical treatment of plaque psoriasis in adults aged ≥18 years.
Approving Regulatory Agency: US FDA
Halobetasol propionate + tazarotene lotion
Trade Name: Duobrii™
Company: Bausch Health
Indication/Description: A new combination formulation corticosteroid/retinoid (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) lotion was approved for improving the signs and symptoms of plaque psoriasis.
Approving Regulatory Agency: Health Canada
Psoriatic Arthritis
Adalimumab biosimilar SC use
Trade Name: Amgevita®
Company: Amgen Canada
Indication/Description: This biosimilar to adalimumab (Humira®) was approved for treating nine chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Adalimumab-fkjp SC use
Trade Name: Hulio®
Company: Viatris (Canada)/Mylan (US) Fujifilm Kyowa Kirin
Indication/Description: This biosimilar to adalimumab (Humira®) was approved for the treatment of multiple chronic diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada, US FDA
Adalimumab biosimilar SC use
Trade Name: Hyrimoz®
Company: Sandoz Canada
Indication/Description: Marketing authorization was granted to this TNF blocker referencing adalimumab (Humira®) for treating the same nine indications, including psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Adalimumab biosimilar SC use
Trade Name: Idacio®
Company: Fresenius Kabi
Indication/Description: This biosimilar referencing adalimumab (Humira®) was approved across all eligible indications including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
Approving Regulatory Agency: Health Canada
Golimumab IV use
Trade Name: Simponi® Aria™
Company: Janssen Pharmaceutical
Indication/Description: Golimumab was approved for treating patients ≥2 years of age with active polyarticular juvenile idiopathic arthritis; this expanded indication also includes active psoriatic arthritis for this patient population.
Approving Regulatory Agency: US FDA
Guselkumab SC use
Trade Name: Tremfya®
Company: Janssen Pharmaceuticals
Indication/Description: An additional indication was approved for this IL-23 receptor inhibitor to treat adult patients with active psoriatic arthritis.
Approving Regulatory Agency: US FDA
Infliximab biosimilar IV use
Trade Name: Avsola™
Company: Amgen Canada
Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, infliximab (Remicade®), including chronic severe plaque psoriasis and psoriatic arthritis.
Approving Regulatory Agency: Health Canada
Rosacea
Minocycline foam 1.5%
Trade Name: Zilxi™
Company: Menlo Therapeutics
Indication/Description: Approval was granted to minocycline 1.5% topical foam for the treatment of inflammatory lesions of rosacea in adults. This approval marks the first minocycline product to be approved by the FDA for use in rosacea.
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.
