| Name/Company | Approval Dates and Comments |
| Isopropyl myristate solution Resultz® Piedmont Pharmaceuticals |
In May 2017, the US FDA granted 510(k) clearance to Resultz® Lice & Egg Elimination Kit, an odorless noninsecticidal product containing isopropyl myristate 50% and ST-cyclomethicone 50%, that kills and removes head lice with a 5-minute application time. This treatment works by dissolving the insect’s waxy exoskeleton, resulting in dehydration and death. |
| Delafloxacin oral and IV formulations Baxdela™ Ligand / Melinta |
The FDA approved delafloxacin in June 2017 for the treatment of adults with acute bacterial skin and skin structure infections 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). |
| Plasma-derived concentrate of C1 esterase inhibitor SC (human) Haegarda® ACSL Behring |
In June 2017, the FDA approved Haegarda®, the first and only selfadministered, twice-weekly, subcutaneous (SC) therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. The safety and efficacy of Haegarda® were established in the Phase III COMPACT trial, which showed that at the approved dose of 60 IU/kg, this therapy reduced the median number of HAE attacks by 95% vs. placebo. |
| Oral dimethyl fumarate Skilarence® Almirall S.A. |
The European Commission (EC) approved this new oral formulation of dimethyl fumarate (DMF) in June 2017 for treating moderate-tosevere chronic plaque psoriasis. Skilarence® is the first DMF, a type of fumaric acid ester (FAE) with anti-inflammatory and immunemodulating properties, approved by the EC for psoriasis. Treatment is indicated for first-line induction and long-term maintenance. |
| Abatacept for IV or SC injection Orencia® Bristol-Myers Squibb |
In July 2017, both the FDA and EC approved abatacept, a selective T-cell co-stimulation modulator, for the treatment of adults with active psoriatic arthritis. The co-stimulation blockade of abatacept inhibits T-cell activation and suppresses the resulting inflammatory cascade. |
| Secukinumab for SC injection Consentyx® Novartis AG |
In July 2017, secukinumab received approval in the EU for a label update that includes 52-week data from the CLEAR study, which demonstrated long-term superiority of secukinumab vs. ustekinumab (Stelara®, Janssen) in psoriasis. The update also includes the use of secukinumab to treat moderate-to-severe scalp psoriasis. This is the first interleukin-17A inhibitor approved to treat psoriasis, psoriatic arthritis and ankylosing spondylitis. |
| Guselkumab for SC injection Tremfya™ Janssen Biotech |
The FDA approved guselkumab in July 2017 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 interleukin (IL)-23. It is administered as a 100 mg SC injection, first at two starter doses at weeks 0 and 4, then every 8 weeks afterwards. |
| Ipilimumab for IV injection Yervoy® Bristol-Myers Squibb |
The FDA approved an expanded indication for ipilimumab in July 2017 to include the treatment of unresectable or metastatic melanoma in pediatric patients ≥12 years of age. The approved ipilimumab dose for pediatric melanoma patients is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses. |
| Belimumab for SC injection Benlysta® GSK |
In July 2017, the FDA approved a new SC formulation of Benlysta® for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. The approval marks the first SC self-injection treatment option for patients with SLE. |
