| Type/Class of Therapy | Generic/Trade/Company Names | Indication/Description | Approving Regulatory Agency |
| Antibiotic Agents | Delafloxacin for oral or IV infusion Baxdela™ Ligand/Melinta | Delafloxacin was approved for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Delafloxacin is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin resistant Staphylococcus aureus (MRSA). | US FDA |
| Ozenoxacin cream, 1% Health Canada: Ozanex™, Cipher/Ferrer US FDA: Xepi™, Medimetriks | This novel topical antibiotic was approved for the treatment of impetigo in patients aged ≥2 months. It is the first bacteriocidal topical antibiotic that has been shown to be effective against resistant bacteria such as MRSA. Ozenoxacin offers a short 5-day twice-daily dosing regimen and has shown bacteriological eradication as early as day 3 of treatment. | Health Canada US FDA | |
| Secnidazole oral granules Solosec™ Symbiomix Therapeutics | Secnidazole was approved for treating bacterial vaginosis (BV) in adult women. Secnidazole is a next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose, and is the first and only single-dose oral therapy for BV. | US FDA | |
| Anti-cancer Agents | Avelumab for IV injection Bavencio® EMD Serono/Merck KGaA | Avelumab, a human anti-programmed cell death-ligand PD-1/PD-L1 antibody, was approved for the treatment of adults and pediatric patients ≥12 years of age with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. | Health Canada US FDA |
| Brentuximab vedotin for IV infusion Adcetris® Seattle Genetics | Approval was granted to brentuximab vedotin for the treatment of adults with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy. | US FDA | |
| Atopic Dermatitis | Dupilumab for SC injection Dupixent® Sanofi/Regeneron | Approval was granted to dupilumab, the first biologic for treating adults with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupilumab is a human monoclonal antibody that specifically inhibits overactive signaling of two key cytokines, interlukin (IL)-4 and IL-13. | Health Canada US FDA European |
| Dermal Fillers | Hyaluronic acid-based injectable dermal filler Juvéderm® Vollure™ XC Allergan plc | This hyaluronic acid (HA) dermal filler was approved for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults >21 years of age. It is formulated with the proprietary Vycross® technology, which blends different molecular weights of HA to provide a longer duration of effect. The product is known as Juvéderm® Volift™™ in Canada and Europe. | US FDA |
| HA injectable filler Revanesse® Ultra Prollenium | Marketing clearance was granted to this non-animal cross-linked HA dermal filler. The product is indicated for injection into the mid to deep dermis, for correction of moderate to severe facial wrinkles and folds in adults ≥22 years of age. | US FDA | |
| HA injectable filler RHA®2, RHA®3 & RHA®4 Teoxane Laboratories | These three HA dermal fillers received marketing clearance and are indicated for the correction of moderate to severe dynamic facial wrinkles and folds in adults aged ≥22 years. | US FDA | |
| Fabry Disease | Oral migalastat Galafold™ Amicus Therapeutics | Approval was granted to migalastat, a first-in-class oral, small molecule, precision therapy for the long-term treatment of adults with a confirmed diagnosis of Fabry disease [deficiency of alphagalactosidase (alpha-Gal A)] and who have an alpha-Gal A mutation determined to be amenable by an in vitro assay. | Health Canada |
| Hereditary Angioedema | Plasma-derived concentrate of C1 esterase inhibitor SC (human) Haegarda® CSL Behring | Approval was granted to Haegarda®, the first and only self administered, twice-weekly therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. Data from the Phase 3 COMPACT trial showed the approved dose of 60 IU/kg reduced the median number of HAE attacks per month by 98% in subjects who had frequent attacks. | Health Canada US FDA |
| Herpes Zoster | Herpes zoster vaccine (non-live recombinant, AS01B adjuvanted) suspension Shingrix GlaxoSmithKline | This non-live, recombinant subunit vaccine was approved for the prevention of herpes zoster (shingles) in adults aged ≥50 years. Shingrix is administered intramuscularly (IM) in two doses. In clinical trials, Shingrix showed 89% efficacy in preventing postherpetic neuralgia in patients ≥70 years of age. No loss of efficacy was observed during the 4-year follow-up period. | Health Canada US FDA |
| Hidradenitis Suppurativa | Adalimumab biosimilar Amgevita™ Amgen | This biosimilar referencing adalimumab (Humira®) was approved in all available indications, including moderate to severe hidradenitis suppurativa. | European Commission |
| Adalimumab-adbm Cyltezo® Boehringer Ingelheim | This biosimilar to adalimumab (Humira®), was approved for the treatment of multiple chronic inflammatory diseases, including moderate to severe hidradenitis suppurativa. | European Commission | |
| Adalimumab biosimilar Imraldi® Samsung Bioepis/Biogen | Imraldi® was approved in the European Union (EU) for all 10 of the current adalimumab (Humira®) indications, including adult and adolescent hidradenitis suppurativa. | European Commission | |
| Psoriasis | Biosimilar to adalimumab for SC injection Amgevita™ Amgen | Marketing authorization was granted for Amgevita™, a biosimilar referencing adalimumab (Humira®), in all available indications, including psoriatic arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe hidradenitis suppurativa. This approval also includes certain pediatric inflammatory diseases, including severe chronic plaque psoriasis (≥4 years of age). | European Commission |
| Adalimumab-adbm for SC injection Cyltezo® Boehringer Ingelheim | This biosimilar to adalimumab (Humira®), was approved for the treatment of multiple chronic inflammatory diseases, including moderate to severe hidradenitis suppurativa. | US FDA European | |
| Adalimumab biosimilar for SC injection Imraldi® Samsung Bioepis/Biogen | Imraldi® was approved in the EU for all 10 of the current adalimumab (Humira®) indications, including psoriatic arthritis, psoriasis, pediatric plaque psoriasis, and adult and adolescent hidradenitis suppurativa. | European Commission | |
| Brodalumab for SC use US FDA: Siliq™, Valeant European Commission: Kyntheum®, Leo Pharma | Approval was granted to brodalumab, a monoclonal antibody that targets the interleukin (IL)-17 receptor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. | US FDA European | |
| Oral dimethyl fumarate Skilarence® Almirall | This new oral formulation of dimethyl fumarate was approved for the treatment of moderate to severe chronic plaque psoriasis. Treatment is indicated for first-line induction and long-term maintenance. | European Commission | |
| Guselkumab for SC injection Tremfya™ MorphoSys/Janssen | Guselkumab was approved for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Guselkumab is a human monoclonal antibody that functions by selectively blocking the cytokine IL-23. | European CommissionHealth CanadaUS FDA | |
| Infliximab-abda for IV injection Renflexis® Samsung Bioepis/Merck | Infliximab-abda, a biosimilar referencing infliximab (Remicade®), was approved across all eligible indications, including treatment of psoriatic arthritis and adult plaque psoriasis. | Health Canada US FDA | |
| Infliximab-qbtx for IV injection Ixifi™ Pfizer | Approval was granted to infliximab-qbtx, a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to infliximab (Remicade®) for all eligible indications of the reference product, including psoriatic arthritis and plaque psoriasis. | US FDA | |
| Psoriatic Arthritis | Abatacept for IV or SC injection Orencia® Bristol-Myers Squibb | Abatacept, a selective T-cell co-stimulation modulator, was approved for the treatment of adults with active psoriatic arthritis (PsA). Abatacept inhibits T-cell activation, thereby blocking the process that triggers the inflammatory cascade implicated in PsA. | US FDA European Commission |
| Biosimilar to adalimumab for SC injection Amgevita™ Amgen | Marketing authorization was granted for Amgevita™ in all available indications, including psoriatic arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe hidradenitis suppurativa. This approval also includes certain pediatric inflammatory diseases, including severe chronic plaque psoriasis (≥4 years of age). | European Commission | |
| Adalimumab-adbm for SC injection Cyltezo™ Boehringer Ingelheim | This biosimilar to adalimumab (Humira®), was approved for the treatment of multiple chronic inflammatory diseases, including active psoriatic arthritis and moderate to severe plaque psoriasis. In Europe, Cyltezo® is also approved for hidradenitis suppurativa. | US FDA European Commission | |
| Adalimumab biosimilar for SC injection Imraldi®, Samsung Bioepis/Biogen | Imraldi® was approved in the EU for all 10 of the current adalimumab (Humira®) indications, including psoriatic arthritis, psoriasis, pediatric plaque psoriasis, and adult and adolescent hidradenitis suppurativa. | European Commission | |
| Golimumab for IV use Simponi Aria® Janssen Biotech | Golimumab, a fully-human anti-tumor necrosis factor-alpha therapy, was approved for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. | US FDA | |
| Infliximab-abda Renflexis® Samsung Bioepis/Merck | Infliximab-abda, a biosimilar referencing infliximab (Remicade®), was approved across all eligible indications, including treatment of psoriatic arthritis and adult plaque psoriasis. | Health Canada US FDA | |
| Infliximab-qbtx for IV injection Ixifi™ Pfizer | Approval was granted to infliximab-qbtx, a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to infliximab (Remicade®) for all eligible indications of the reference product, including psoriatic arthritis and plaque psoriasis. | US FDA | |
| Ixekizumab for SC injection Taltz® Eli Lilly and Company | Ixekizumab was approved for the treatment of adults with active psoriatic arthritis. This is a humanized anti-IL-17 monoclonal antibody that was first approved by the FDA in 2016 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. | US FDA | |
| Tofacitinib tablets Xeljanz® Pfizer | Approval was granted to Xeljanz® 5 mg twice daily and Xeljanz® XR extended release 11 mg once daily for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. | US FDA | |
| Rosacea | Oxymetazoline hydrochloride 1% cream Rhofade™ Allergan | Approval was granted for oxymetazoline hydrochloride 1% cream to treat persistent facial erythema (redness) associated with rosacea in adults. Oxymetazoline hydrochloride, an alpha-1A-adrenoceptor agonist and a partial agonist at the alpha-2 receptor, diminishes erythema through vasoconstriction. | US FDA |
| Seborrheic Keratosis | Hydrogen peroxide topical solution Eskata™ Aclaris Therapeutics | Approval was granted to this hydrogen peroxide topical solution, 40% (w/w) for treating raised seborrheic keratosis (SKs). Treatment is administered through a pen-like applicator directly onto the SK site by a healthcare professional. In Phase 3 trials, patients treated with the solution were more likely to be completely cleared of SKs after 2 treatments vs. placebo. | US FDA |
| Systemic Vasculitis | Mepolizumab for SC injection Nucala® GlaxoSmithKline | Expanded use was granted for mepolizumab, a humanized interleukin-5 antagonist monoclonal antibody, to include treating adults with eosinophilic granulomatosis with polyangiitis (EGPA). This new indication provides the first FDA-approved targeted treatment for EGPA, previously known as Churg-Strauss syndrome. | 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. | |||
