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Update on Drugs and Drug News: September-October 2016


Name/Company Approval Dates and Comments

Pembrolizumab IV injection
Keytruda®
Merck & Co.

In May 2016, pembrolizumab received approval from Health Canada for the treatment of patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Pembrolizumab is now the first and only anti-PD1 agent approved for first-line treatment regardless of BRAF mutation status.

Hyaluronic acid gel filler
Juvéderm Volbella® XC
Allergan plc

Approval was granted by the US FDA in May 2016 to market Juvéderm Volbella® XC for use in the lips for lip augmentation and correction of perioral rhytids, commonly referred to as perioral lines, in adults > 21 years of age.

Biosimilar of infliximab
Flixabi®
Samsung Bioepis Co.

In May 2016 the European Commission's (EC) approved Flixabi® (also known as SB2), an infliximab biosimilar referencing Remicade®, for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn's disease, ulcerative colitis, and ankylosing spondylitis. This EC approval applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Ceftaroline fosamil for IV infusion
Teflaro®
Allergan plc

The FDA approved a supplemental New Drug Application (sNDA) in May 2016 for ceftaroline fosamil, granting new indications for pediatric patients 2 months to <18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.

Dermal filler with calcium hydroxylapatite (CaHA) + integral 0.3% lidocaine
Radiesse® Lidocaine
Merz Pharma

The EU granted CE Mark certification in June 2016 to Radiesse® Lidocaine, an injectable implant dermal filler that contains a small quantity of the local anesthetic lidocaine. In Europe, Radiesse® Lidocaine is indicated for plastic/reconstructive procedures, including deep dermal and subdermal soft tissue augmentation of the facial area and for restoration and correction of facial volume loss. The presence of lidocaine is intended to reduce patient pain and to enhance comfort during treatment.

Ixekizumab SC injection
Talz®
Eli Lilly and Company

In June 2016, Health Canada approved ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Ixekizumab is an antibody specifically designed to target the cytokine interleukin IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

Adapalene gel 0.1%
Differin® Gel
Galderma Laboratories

In July 2016, the FDA approved Differin® Gel 0.1% as an overthe- counter (OTC) treatment for acne. This approval makes Differin® Gel the first and only OTC acne product containing a full prescription-strength retinoid. It also marks the first new FDA-approved active ingredient to be introduced to the OTC acne category in over 3 decades.

C1 esterase inhibitor(human) for IV infusion
Berinert®
CSL Behring

In July 2016, the FDA broadened the approval of C1 esterase inhibitor (human) to include treating hereditary angioedema (HAE) attacks in pediatric patients. This expands the use of Berinert® into all age groups, making it the first and only approved HAE treatment available to patients < 12 years of age.


In this issue:

  1. Sodium Deoxycholate for Submental Contouring
  2. Rituximab: Uses in Dermatology
  3. Update on Drugs and Drug News - September-October 2016