Secukinumab for SC use
Trade Name: Cosentyx®
Approval Dates/Comments: The US FDA approved secukinumab in June 2021 for pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis. This expanded approval marks the first for a pediatric patient population in the US. Secukinumab is a fully human biologic agent that inhibits interleukin-17A (IL-17A) directly. The IL-17A is considered a “cornerstone cytokine” implicated in inflammation as well as the development of psoriasis and psoriatic arthritis.
Brincidofovir tablets and oral suspension
Trade Name: Tembexa®
Approval Dates/Comments: The FDA approved the oral antiviral brincidofovir in June 2021 for the treatment of smallpox in adult and pediatric patients, including neonates. Brincidofovir is a lipid conjugate of cidofovir with good oral bioavailability. The compound is designed to release cidofovir intracellularly, allowing for higher intracellular and lower plasma concentrations of cidofovir, thereby increasing its activity against double-stranded DNA viruses.
Trade Name: Ryplazim®
Company: Liminal BioSciences
Approval Dates/Comments: In June 2021, the FDA approved this plasma-derived human plasminogen for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can impair normal tissue and organ function. Affected individuals lack a protein called plasminogen, which is responsible for the ability of the body to break down fibrin clots. Plasminogen deficiency leads to an accumulation of fibrin, causing the development of lesions that can impair normal tissue and organ function. With this approval, Ryplazim® becomes the first FDA approved therapy for this rare genetic disorder.
Halobetasol propionate lotion 0.01% w/w
Trade Name: Bryhali™
Company: Bausch Health
Approval Dates/Comments: Health Canada approved halobetasol propionate lotion 0.01% w/w, a high to super-high potency topical corticosteroid, in May 2021 for treating corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis. Common corticosteroid-responsive dermatoses include seborrheic dermatitis and eczematous dermatoses (e.g., atopic dermatitis and contact dermatitis).
Nomacopan for SC use
Trade Name: (formerly known as Coversin)
Company: Akari Therapeutics
Approval Dates/Comments: In April 2021, the FDA granted Fast Track designation to nomacopan for the treatment of patients with moderate and severe bullous pemphigoid (BP). Nomacopan has also been granted Orphan Drug designation for the treatment of BP by the US FDA and the European Medicines Agency (EMA). Nomacopan is a C5 complement inhibitor that independently and specifically binds to and inhibits leukotriene B4 (LTB4) activity. In patients with BP, there is evidence that nomacopan’s ability to inhibit C5 and LTB4 gives it a unique potential therapeutic advantage, which is upstream of other approaches (such as cytokine inhibitors) that are being investigated for the treatment of BP. A multicenter Phase III study of nomacopan for the treatment of moderate and severe BP has been initiated. Nomacopan has the potential to replace long-term steroid treatment (standard of care) in BP, which has multiple adverse effects and increases mortality in this elderly and frail population.