|Approval Dates and Comments
|Dupilumab for SC injection
|In March 2017, the US FDA approved dupilumab, the first biologic for treating adults with moderate-to-severe atopic dermatitis (AD) 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, interleukin (IL)-4 and IL-13, which are believed to play a pivotal role in driving the chronic underlying inflammation in AD. Dupixent® comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose, and can be used with or without topical corticosteroids. Most common adverse reactions (≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.
|Dupilumab for SC injection
|The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a positive opinion in March 2017 for dupilumab in atopic dermatitis (AD) under the Early Access to Medicines Scheme (EAMS). The decision allows eligible patients to receive the treatment prior to the drug gaining marketing authorization in the EU. Under the early access scheme, patients must have severe AD and failed to respond to, be intolerant to, or be ineligible for other therapies.
|Avelumab for IV injection
EMD Serono/Merck KGaA
|In March 2017, the FDA approved avelumab, a human antiprogrammed cell death ligand-1 (PD-L1) antibody, for the treatment of adults and pediatric patients ≥12 years of age with metastatic Merkel cell carcinoma (mMCC), including those who have not received prior chemotherapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This marks the first FDA-approved treatment for mMCC.
|Hyaluronic acidbased injectable dermal filler
|The FDA approved this hyaluronic acid (HA) dermal filler in March 2017 for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, in adults >21 years of age. Formulated with the proprietary Vycross® technology, which blends different molecular weights of HA, the product provides a longer duration of effect. Data from a clinical study showed 59% of patients had an improvement for up to 18 months. Additionally, 82% of patients reported they were very satisfied at 6 months and 68% of patients at 18 months. The product is known as Juvéderm® Volift™ in Canada and Europe, with approvals gained in 2014 and 2013, respectively.
|Adalimumab for SC injection
|In March 2017, the FDA approved the inclusion of moderate-to-severe fingernail psoriasis data in the adalimumab (Humira®) prescribing information for patients with moderate-to-severe chronic plaque psoriasis. Adalimumab is now the first-and-only biologic treatment with Phase 3 data on fingernail psoriasis in its US prescribing information. The study demonstrated nearly half of adult patients achieved an assessment of clear or minimal with at least a two-grade improvement from baseline in signs and symptoms of fingernail psoriasis compared to 6.9% of placebo (p<0.001).
|Biosimilar to adalimumab for SC injection
|In March 2017, the European Commission (EC) granted marketing authorization 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).