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Update on Drugs and Drug News: September-October 2017


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.


In this issue:

  1. Vitamin B Derivative (Nicotinamide) Appears to Reduce Skin Cancer Risk
  2. Epidermal Growth Factor Receptor Inhibitors: Cutaneous Side Effects and Their Management
  3. Update on Drugs and Drug News - September-October 2017