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Update on Drugs and Drug News: January-February 2017


Name/Company Approval Dates and Comments

Nivolumab + ipilimumab
Opdivo® + Yervoy®
Bristol-Myers
Squibb Company

In October 2016, Health Canada granted conditional approval to the nivolumab (Opdivo®) + ipilimumab (Yervoy®) regimen for the treatment of previously untreated adults with unresectable or metastatic melanoma. This new therapeutic option consists of the firstever combination of two immuno-oncologic agents targeting distinct and complementary immune pathways at the same time, resulting in the potential to increase progression-free survival in certain patients. Health Canada also issued a notice of compliance with conditions for Opdivo® monotherapy for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in previously untreated adults. An improvement in survival has yet to be established for either indication.

Etanercept for SC injection
Enbre®
Amgen Inc.

The US FDA approved the supplemental Biologics License Application (sBLA) for the expanded use of etanercept (Enbrel® in November 2016, making it the first and only systemic therapy to treat pediatric patients aged 4-17 with chronic moderate-to-severe plaque psoriasis. The approval is based on results from a Phase III 1-year study and its 5-year open-label extension study to evaluate the safety and efficacy of Enbrel® in pediatric patients with chronic moderate-to-severe plaque psoriasis. In addition to demonstrating significant efficacy, the adverse events were similar to those seen in previous studies in adults with moderate-to-severe plaque psoriasis. Enbrel® is a tumor necrosis factor (TNF) blocker that was first approved in 1998 to treat moderateto- severe rheumatoid arthritis. It was subsequently approved in 1999 to treat polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, in 2003 to treat ankylosing spondylitis, and in 2004 to treat plaque psoriasis in adults.

Crisaborole 2% ointment
Eucrisa
(formerly AN2728)
Pfizer/Anacor

The FDA approved crisaborole ointment in December 2016 to treat mild-to-moderate eczema (atopic dermatitis) in patients ≥2 years of age. Cisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor that is applied topically twice daily. Crisaborole is a boron-based small molecule that appears to inhibit PDE-4 in target cells, thereby inhibiting the production of proinflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis. Safety and efficacy were established in two placebocontrolled trials with a total of 1522 participants, ranging in age from 2-79 years, with mild-to-moderate atopic dermatitis. Overall, participants receiving topical cisaborole achieved greater response with clear or almost clear skin after 28 days of treatment.

Hyaluronic acid dermal fillers
Restylane® Refyne
Restylane® Defyne
Galderma
Laboratories

The FDA approved two new next generation hyaluronic acid (HA)- based dermal fillers in December 2016 for the treatment of nasolabial folds or laugh lines in patients >21 years of age. Restylane® Refyne was approved for moderate-to-severe facial wrinkles and folds and Restylane® Defyne for treating moderate-to-severe deep facial wrinkles and folds. These HA fillers have been shown to maintain efficacy for treating nasolabial folds for up to 12 months and are manufactured with XpresHAn technology, which customizes the degree of HA crosslinking in each product to allow a range of flexibly and support. According to the manufacturer, distinct from fillers already commercially available, the XpresHAn technology allows the product to move within the face as facial expressions are made, resulting in a more natural-looking outcome. Although new to the US, both Restylane® Refyne and Defyne gained approval in the EU under the name trade name of Emervel® in 2010.


In this issue:

  1. A Dermatologist's Guide to Infection Screening Prior to Initiating Immunosuppressive Therapy
  2. Update on Drugs and Drug News - January-February 2017