|Name/Company||Approval Dates and Comments|
Health Canada issued a Notice of Compliance in August 2015 approving Varithena® (polidocanol injectable foam) for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system, above and below the knee. Varithena® is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. Treatment is minimally invasive, non-surgical (no incision) and requires neither tumescent anesthesia nor sedation.Varithena® is intended for use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound.
Cobimetinib + vemurafenib
Cotellic™ + Zelboraf®
In August 2015, Swissmedic, the Swiss licensing and supervisory authority of Switzerland, approved cobimetinib for use in combination with vemurafenib (BRAF-inhibitor) as an oral treatment for patients with advanced melanoma. Cobimetinib is a selective inhibitor of MEK. Combined inhibition of BRAF + MEK is thought to improve outcomes in melanoma by preventing or delaying the onset of resistance seen with BRAF inhibitors alone.
Adalimumab SC injection
The FDA approved this tumor necrosis factor-alpha (TNF-α) inhibitor in September 2015 for the treatment of moderate to severe hidradenitis suppurativa (HS, acne inversa). Adalimumab is the first and only FDA-approved therapy for adults with HS. The anti-inflammatory effects of TNF-α inhibition are believed to influence the pathogenic mechanisms in HS. In July, the European Commission approved Humira® for the treatment of active moderate to severe HS in adults with an inadequate response to conventional systemic HS treatment in the European Union.
Hyaluronic acid filler
Juvederm® Ultra XC
The FDA granted marketing approval in October 2015 to this hyaluronic acid-based dermal filler for injection into the lips and perioral area for lip augmentation in adults >21 years of age.
Nivolumab + ipilimumab
Opdivo® + Yervoy®
The FDA approved nivolumab in combination with ipilimumab in October 2015 for the treatment of patients with BRAF V600 wildtype unresectable or metastatic melanoma. This marks the first and only FDA approval of a novel regimen that demonstrated the potential of targeting distinct and complementary immune system pathways. Pivotal study CheckMate -069 showed significantly superior responses and progression-free survival with the nivolumab (PD-1 inhibitor) + ipilimumab (CTLA-4 inhibitor) regimen vs. ipilimumab alone. This indication received accelerated approval based on tumor response rate and durability of response.
Ingenol mebutate gel
In August 2015, the FDA issued a warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of ingenol mebutate gel. Picato® is indicated for the treatment of actinic keratosis. The agency has also received reports of cases involving severe eye injuries and skin reactions- some cases occurred when the drug was not applied according to the recommendations on the label. Consequently, the FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product.