| Name/Company | Approval Dates/Comments |
| Hydrogen peroxide topical solution Eskata™ Aclaris Therapeutics |
The US FDA approved Eskata™ (hydrogen peroxide) topical solution, 40% (w/w) in December 2017 for treating raised seborrheic keratosis (SKs). This preparation is a proprietary, high concentration hydrogen peroxide-based topical solution intended for in-office application by a healthcare provider and is not for use at home. It is a targeted treatment applied directly to the raised SKs using a pen-like applicator. |
| Mepolizumab for SC injection Nucala® GSK |
In December 2017, the FDA expanded the approved use of mepolizumab, a humanized interleukin-5 antagonist monoclonal antibody, to include treating adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved targeted treatment for EGPA, previously known as Churg-Strauss syndrome. |
| Brentuximab vedotin for IV use Adcetris® Seattle Genetics Takeda |
In January 2018, the European Commission extended the current conditional marketing authorization for brentuximab vedotin to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma, including CTCL. |
| Device News | |
| Cryolipolysis for submental fat reduction CoolSculpting® Allergan |
In December 2017, the FDA granted clearance to CoolSculpting® treatments for improved appearance of lax tissue in conjunction with submental fat, or double chin. CoolSculpting® for the double chin has been clinically demonstrated to reduce fat up to 20% in the treated area after one treatment. |
| Perfluorodecalin (PDF) patch DeScribe® PFD Patch ON Light Sciences Merz |
Expanded FDA clearance of the DeScribe® Transparent, single-use PFD (perfluorodecalin) patch was granted in December 2017 for use with additional lasers and wavelengths in laser-assisted tattoo removal. The patch was initially cleared in April 2015 for use with the 755nm Q-Switched (QS) Alexandrite laser, which effectively removes blue or black ink tattoos. The expanded approval now includes the use of 532nm, 694nm, 755nm, and 1064nm standard QS lasers, as well as the 532nm, 755nm, 785nm, and 1064nm standard picosecond lasers in Fitzpatrick Skin Type I–III patients. This allows for the removal of tattoos for a wider spectrum of colors, as well as enables the delivery of multiple laser passes in a single treatment session. This expanded FDA clearance also includes an extended shelf life of the patch from 2 to 3 years. |
| Adhesive patch for melanoma detection Pigmented Lesions Assay (PLA) DermTech |
In January 2018, Health Canada approved the license to market the Pigmented Lesions Assay (PLA) and non-invasive biopsy kit for the detection of melanoma. This cancer detection platform represents a non-invasive alternative for the biopsy of clinically atypical pigmented lesions (or moles) using an adhesive patch. Collected skin biopsy samples will be analyzed at a central laboratory in La Jolla, California to detect two specific genes, PRAME and LINC00518 – elevated expression of these genes are linked to melanoma. Data from two validation studies in 158 patients with non-melanoma or melanoma lesions demonstrated 93% sensitivity and 90% specificity for detecting melanoma. |
